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Pharmaceutical Microbiology UK
21 January - 22 January 2019
Pharmaceutical Microbiology UK

SAE Media Group’s 8th Annual Conference
Pharmaceutical Microbiology UK
January 21 - 22, 2019 | London, United Kingdom
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The pharmaceutical microbiology industry has seen many changes during the progression into the 21st century. With advances in rapid microbiological methods, revisions being made to regulations in the industry, enhanced knowledge of the human microbiome, and novel testing methods, this industry is ever expanding. In fact, the value of the rapid microbiology testing market is expected to reach USD 6.2 Billion by 2022, expanding at a CAGR of 7.3% from 2016 to 2022.


Join industry experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss the revision of Annex 1, gain insight into novel rapid microbiology methods, explore case studies on contamination control and consider the issues surrounding data integrity.
 

FEATURED SPEAKERS

Di Morris

Di Morris

Senior Manager, Team Leader, Vaccines Quality Audit, GSK
James  Drinkwater

James Drinkwater

Chairman, Pharmaceutical and Healthcare Sciences Society
Jim Polarine

Jim Polarine

Senior Technical Service Manager, STERIS Corporation
Olivier Chancel

Olivier Chancel

Sterility and Aseptic Process Assurance Expert, Boehringer Ingelheim
Renate Rosengarten

Renate Rosengarten

Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna
Tim Eaton

Tim Eaton

Sterile Manufacturing Specialist, AstraZeneca

Alexander Stoll

Vice President, Head of Competence Center Microbiology and Aseptic Techniques, Fresenius Kabi
Alexander Stoll

Born on 28 November 1972 in Germany, always having a high interest in the field of molecular biology, Alexander Stoll completed his PhD thesis in Microbiology/Genetics during September 2001 at the University of Kaiserslautern. After moving to Sweden, he started working in December 2001 for Fresenius Kabi sterile international manufacturing plant in Uppsala, leading a group of microbiologists responsible for microbiological qualification of sterilization processes. Throughout the years Alexander has been holding different management positions for the Swedish manufacturing plants within Quality Control, Quality Assurance and as a Qualified Person. Starting 2012 he had responsibility as a Global Operations QA head, with regional QA and plant QA functions directly reporting to him. In his current position as Vice President Competence Center Microbiology & Aseptic Technique he has built a group of subject matter experts working with all pharmaceutical Fresenius Kabi manufacturing sites and compounding centers, setting global standards. Throughout the years he has gained intensive hands-on experience from different sterile manufacturing techniques for finished medicinal product & API and multiple international authority inspections.

Bill Keevil

Scientific Advisor to the House of Commons Select Committee on Science & Technology, Head of the Microbiology Group and Director of the Environmental Healthcare Unit. University of Southampton, UK, University of Southampton
Bill Keevil

Di Morris

Senior Manager, Team Leader, Vaccines Quality Audit, GSK
Di Morris

Di Morris - MRSC Chemistry and PGDiPS and a Qualified Person under permanent provisions since 1993; Pharmaceutical industry for over 30 years/ a number of years as a Medicines Inspector for the MHRA. Di/worked in the areas of Quality Control (Chemistry and Microbiology), Quality Assurance and Regulatory Affairs/worked with a wide range of dosage forms including sterile products, biological, and non-sterile products.

James Drinkwater

Chairman, Pharmaceutical and Healthcare Sciences Society
James  Drinkwater

James Drinkwater is Head of Aseptic processing technologies & GMP compliance for F Ziel Germany, supporting international projects from a base in the UK. As a subject matter expert in Barrier separation technology; Isolator / RABS and hydrogen peroxide vapour bio-decontamination, James is involved in applications of sterile pharmaceutical product Filling, Aseptic processing of APIs/ ATMPs and Sterility testing.
In addition to the role at F Ziel James has a voluntary role as Chairman of the not for profit society: PHSS – Pharmaceutical and Healthcare sciences society and leads the PHSS Aseptic processing & Bio-contamination special interest group.
 

James Cannon

Head of OEM and Markets, Mettler-Toledo Thornton
James Cannon

Jim Cannon is Head of OEM and Markets at Mettler-Toledo Thornton, he has a B.S. in Biology, degrees in Microbiology and Biophysics, and an MBA in Marketing and International Management. Mr. Cannon has over 35 years of experience in the management, design and development of ultrapure water treatment and technology. This includes measuring differential conductivity and UV oxidation for the detection of TOC in UPW and the design and commercialisation of electrodeionisation modules. Mr Cannon is currently involved in the standards and regulatory organisations for the Semiconductor, Photovoltaic and Pharmaceutical markets, and the commercialisation of alternative microbial technology.
 

Jim Polarine

Senior Technical Service Manager, STERIS Corporation
Jim Polarine

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for seventeen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches the cleaning and disinfection course at the PDA Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is currently President Elect for the PDA Missouri Valley and Technical Coordinator for IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

Laurent LeBlanc

R&D Healthcare Culture Media Manager, Biomerieux
Laurent LeBlanc

Laurent Leblanc is R&D manager for bioMerieux’ Healthcare business. He holds a Master’s degree in Biotechnology from the University of Limoges, France. For the last 15 years, he worked in several biotechnology companies and before joining bioMerieux in 2008 worked in microbiological quality control in the pharmaceutical industry. He is now involved in designing and bringing to the market the new innovative and efficient solutions dedicated to the pharmaceutical and cosmetic industries.

Marine Marius

Scientist, Analytical Research and Development Europe, Sanofi Pasteur
Marine Marius

Marine Marius is Scientist in the Analytical Sciences department of Sanofi Pasteur in the Microbiology/Virology platform. She leads the development, validation and implementation of rapid microbiology methods (bacteriology and molecular biology) for legacy and investigational products. She is an internal SME in endotoxin, mycoplasma and mycobacteria testing. Marine holds a M.Sc. in Biotechnology and Applied Microbiology from ESIL University (Ecole Supérieure d’Ingénieurs de Luminy) in France.

Morgan Polen

Contamination Control and Cleanroom Expert, Microrite, Inc.
Morgan  Polen

Morgan Polen has been involved with cleanrooms and contamination control since 1984. He has worked in over 40 countries involved with projects ranging from cleanroom design, construction, validation, AFV, monitoring program development, particle counter design and product management for cleanroom related products and systems. He has addressed monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical and others. Morgan is a member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms and Associated Controlled Environments, participating in the process of adapting the latest cleanroom standards.

Olivier Chancel

Sterility and Aseptic Process Assurance Expert, Boehringer Ingelheim
Olivier Chancel

Doctor Pharmacist, graduated in technological pharmacy, quality control and management. Currently Sterility and Aseptic Practice Assurance Expert and formerly Head of Performance and Pharmaceutical Support in Boehringer Ingelheim, Toulouse, France. Provide a corporate support on sterility and aseptic processes to Boehringer Ingelheim Animal Health sites. Used to work in or with the pharmaceutical industry for 15 years at various positions including pharmaceutical research and development, Quality Assurance, Quality Control, project management and production for both solid and injectable dosage forms.

Philippe Dutot

Sterility Assurance Specialist, Novo Nordisk
Philippe Dutot

Philippe DUTOT is Engineer in Biotechnology and he owns a PhD in Molecular and Cellular Biology.
He has around 25 years of experience in biotech and pharmaceutical industries at different management and specialist positions in R&D, Scale-up of Production, Quality Control and Quality Assurance. He is currently Sterility Assurance Specialist at Novo Nordisk Production - France in a facility dedicated to manufacture of aseptic products. He is also Corporate Lead Auditor for his company.

 

Renate Rosengarten

Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna
Renate Rosengarten

Professor Renate Rosengarten’s career originated from science and research through her work in academia which is for more than 40 years marked by a continuous interest in the infection biology of mycoplasmas, and their detection, prevention and control. Her passion for mycoplasmas took her to the University of Veterinary Medicine Hannover in Germany, the University of Missouri-Columbia in the US, and the Hadassah Medical School of the Hebrew University in Jerusalem, Israel. Since 1996 she is Professor and Chair of Bacteriology and Hygiene at the University of Veterinary Medicine Vienna in Austria.
Besides her numerous former functions and activities in organizations and committees, such as President of the International Organization for Mycoplasmology (IOM), President of the Austrian Society for Hygiene, Microbiology and Preventive Medicine (ÖGHMP), and Working Group Leader of the Mycoplasma Task Force of the Parenteral Drug Association (PDA), Prof Rosengarten has long-standing entrepreneur and business experience in the biotech area. She was the Founder and Managing Director of the previous niche market leader Mycosafe Diagnostics which she has in 2014 re-established under the company name Mycoplasma Biosafety Services. Prof Rosengarten started the company in 2004 as a university spin-off and built it from scratch to a technological innovation leader in the area of Industrial and Pharmaceutical Mycoplasmology, offering GMP-compliant mycoplasma testing, validation and contract research services.
In addition to her management and business activities and her academic duties as a lecturer, reviewer, committee and advisory board member, Prof Rosengarten also serves as an independent mycoplasma expert, key opinion leader and consultant for biopharma and biotech companies under her own international brand Mycosafe.

Rosemary Versteegen

CEO, International Serum Industry Association
Rosemary Versteegen

Dr Versteegen received her B.Sc. and Ph.D. degrees in Biochemistry from Glasgow University, Scotland. She held Postdoctoral scholarships at Cambridge University, England and the National Institutes of Health working in areas of disease research. Following several years in NIH sponsored cancer research programs, she joined Life Technologies and held various key roles, both technical and business oriented, including Vice President of the GIBCO Manufacturing Facility, Vice President of Regulatory Affairs, Vice President of New Business Development and Vice President of Strategic Planning. In 2000, Dr Versteegen became a founding partner of the Lifia Group, a consulting organization focused on helping life science and biotechnology companies grow through clearly enunciated, actionable strategic plans. Since its inception in 2006, Dr Versteegen has been the CEO of the International Serum Industry Association, a global life science not-for-profit association. The mission of the Association is to establish, promote and assure compliance with uncompromised standards of excellence and ethics in the business practices of the global animal serum and animal derived products supply industry. The primary focus is on safety and safe use of serum and animal derived products through proper origin traceability, truth in labeling, and appropriate standardization and oversight.
 

 

Sonia Allibardi

Market Access Manager, Copan Italia SpA
Sonia  Allibardi

Molecular biologist with a specialization degree in Biochemistry Science. Currently working in the Scientific Team of COPAN as Market Access Manager for the implementation of innovative Medical Devices in pre-analytics focusing on Italy, Eastern Europe and Asia Pacific Market. Her professional life started in a research Cardiovascular Physiology laboratory at San Raffaele Scientific Institute, Milan Italy, where she worked for more than 10 years and published scientific papers on International Journals. The objective of her research was the evaluation of myocardial metabolism in hypoxic and ischemic heart. In 2011, thanks to the “Mad Cow Disease”, she started a new job in Biorad Company. She spent three years as scientific product specialist in the life science division for Italy and Southern Europe (Spain, Greece, Portugal). She moved to Cepheid Europe for five years where her main topics were: Women’s Health, Hospital Acquired Infection and Tuberculosis.

Steve Simoneau

Biological Safety Project Manager, The LFB Group
Steve Simoneau

Dr. Simoneau received his PhD on prion diseases in 2004 and until 2009 was part of the NeuroPrion management group that aimed to structure and integrate the expertise of more than 90% of the leading Prion research groups in Europe. He then joined the Corporate Biological Safety Surveillance team of LFB, a plasma product manufacturing company, as a biological safety project manager. Amongst his other missions, he piloted research projects in the field of bioslogical afety, contributed to viral and prion risk assessments and provided his biological safety expertise to subsidiaries of LFB. Dr. Simoneau is an expert on prion diseases and has been a member of the International Safety Advisory Committee (ISAC) from 2009 – 2017, that provided scientific guidance to LFB on biological safety aspects.

Thierry Bonnevay

Microbiology Platform Head Analytical Research & Development, Sanofi Pasteur
Thierry Bonnevay

Thierry Bonnevay obtained his Pharm. D pharmacist with special degree in Industrial Pharmaceutical Microbiology in 1996. He joined Sanofi Pasteur in 1997 as QC Bacteriology manager in Industrial Operation. He joined the Analytical Research and Development Department in 2004 and since that time he worked in the development, the validation and the implementation of Microbiology alternatives methods based on bacteriology and molecular biology for commercialized products and clinical products. He is currently Microbiology Platform Leader in Analytical R&D and part of the USP expert panel in Modern Microbiological Methods (MMM) since 2015. He is member of Groups of Experts at the European Pharmacopoeia EDQM Group 1 Microbiology since November 2016 and Working Party Bacterial Endotoxin Test (WP BET) since November 2017.

Thierry Wagner

Regulatory Affairs Director Europe, Middle East and Africa, Dupont De Nemours (Luxembourg) S A
Thierry Wagner

Thierry Wagner has spent over 30 years working for DuPont in its polyester films and nonwovens businesses in a variety of assignments ranging from process development and project management to operations and business management. He is chairman of the board of the Sterile Barrier Association (SBA), member of the Parenteral Drug Association (PDA) and actively involved in various ISO and CEN technical committees on medical and pharmaceutical packaging like ISO TC198 “Sterilization of Health Care Products” on Packaging (ISO 11607) as well as Aseptic Processing, CEN TC102 “Sterilizers for Medical Purposes” (packaging and VH2O2 sterilisers) and ISO TC76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use”. Thierry is also a member of ISO/TC 210 in charge of ISO 13485, ASTM Committee F02 – Flexible Barrier Packaging and of the CEN ABHS (Advisory Board for Healthcare Standards - Europe).
Thierry Wagner earned a master’s degree in mechanical and process engineering from ETH Zürich in Switzerland. He is a featured speaker at international conferences and seminars on medical and pharmaceutical packaging regulatory aspects.

Tim Eaton

Sterile Manufacturing Specialist, AstraZeneca
Tim Eaton

Tim Eaton B.Sc. (chemistry) has over 25 years’ experience of sterile manufacture with Zeneca Pharmaceuticals and AstraZeneca. During this time he has had extensive roles in technical support, production management and specialist activities for aseptically prepared products. He has had responsibilities for the design, construction, start up and validation of multimillion pound aseptic manufacturing facilities and has managed the introduction, technical transfer and scale up activities for a number of sterile products. He has published a number of papers relating to cleanroom activities and has also presented at various industry forums in Europe, Asia and the US.
In his current role of Sterile Manufacturing Specialist he has responsibilities for the derivation, optimisation and implementation of best practices for aseptically prepared products. He sits on LBI/30, the British Committee for Cleanroom Technology.
 

Ziva Abraham

Founder and CEO, Microrite
Ziva Abraham

Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation.
Ziva has over 25 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi for her PhD degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.
 

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Olivier Chancel, Sterility and Aseptic Process Assurance Expert, Boehringer Ingelheim

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9:10

Challenges in development of a contamination control strategy for different product types

Di Morris, Senior Manager, Team Leader, Vaccines Quality Audit, GSK

  • What is expected to be included in a contamination control strategy as a GMP requirement outlined in the revised (draft) Annex 1
  • Contamination control strategy for different product types: Sterile Non-Hazardous, Aseptic Toxic, Aseptic Highly Potent (including ADC’s), Aseptic Sensitising (Hormones)
  • Contamination control strategy and linkage to cross contamination
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    9:50

    Series of learning experiences on contaminations: poor understanding of some microbiological aspects associated with still common preventive maintenance issues

    Olivier Chancel, Sterility and Aseptic Process Assurance Expert, Boehringer Ingelheim

  • Damaged gaskets in mixers
  • Bad setting of travel stops
  • Bad assembly of diaphragm valves
  • Inappropriate inner diameter of gaskets
  • Silicone sealants of panels and self-contained clean rooms
  • Pressure differentials of hydrophobic filters
  • How tight is hand tight?
     
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    10:30

    Morning Coffee

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    11:00

    Quality risk management of clean room garments and sterile packaging solutions for materials, equipment, components and ancillary items for aseptic processing

    Thierry Wagner, Regulatory Affairs Director Europe, Middle East and Africa, Dupont De Nemours (Luxembourg) S A

  • Assessing microbial barrier properties of porous materials
  • Particulate release is a key risk factor to consider: tests for ranking of materials
  • Implementing a contamination control strategy covering the entire product life cycle: from quality-by-design, through qualifications and risk assessments of implemented solutions to thorough operations management
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    11:40

    The strengths and weaknesses of Vaporised Hydrogen Peroxide as a bio-contamination control agent in GMP applications

    James Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

  • Application of VHP/vH202 in bio-contamination control
  • Strengths considering principle attributes and qualification as a broad spectrum sporicidal agent
  • Weaknesses and fragility considered in the MHRA log
  • Principle scientific facts and variance in H202 vapour delivery and cycle control
  • Does the attention of the regulatory agencies mean the ‘Death of the VHP process’ or is the ‘Death of scientific ignorance’ the real purpose of the Blog?

     

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    12:20

    Networking Lunch

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    13:30

    Case studies in deinococcus and fungal and bacterial spores in cleanrooms

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

  • The complexities of CAPA excursion investigations
  • Ways to proactively limit bacterial and mold spore contamination from incoming items into cleanrooms
  • Current industry regulations in the US and Europe with relation to sporicides and disinfectants
  • Recent case studies on new antimicrobial chemistries and their performance against fungal and bacterial spores in cleanrooms
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    14:10

    Mold contamination challenges

    Ziva Abraham, Founder and CEO, Microrite

  • Understanding mold
  • Understanding disinfection and disinfectant qualification as it relates to mold
  • Investigation mold contaminations
  • Clinical relevance of objectionable mold

     

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    14:50

    Case study on using contamination recovery rates to measure performance and improve contamination control

    Alexander Stoll, Vice President, Head of Competence Center Microbiology and Aseptic Techniques, Fresenius Kabi

  • Use of contamination recovery rates as an effective tool for cleanroom monitoring
  • How to use these metrics to improve your contamination control
  • Case study showing step change in the metrics, and thus showing improvement in contamination control
     
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    15:30

    Afternoon Tea

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    16:00

    Case study: Use of applied methodology for the transfer of moist heat sterilised parts from an autoclave to RABS aseptic processing line with Grade A continuity

    Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca

  • Principles of Grade A continuity and how to implement solutions in process operations
  • Definition, classification and qualification of localised uni-directional airflow used as aerodynamic protection of autoclave unload and loading of transfer carts and unload of transfer carts into RABS aseptic process line
  • Transfer cart case study: maintaining sterile integrity of sterilised parts in transfers
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    16:40

    Smoke studies: Misconceptions and regulatory implications

    Morgan Polen, Contamination Control and Cleanroom Expert, Microrite, Inc.

  • Regulatory expectations and recommendations
  • Myths and facts about AFV- where mistakes are made
  • Discussion of FDA 483s related to smoke studies
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    17:20

    How Dead is Dead? The problem of VBNC bacteria

    Bill Keevil

    Bill Keevil, Scientific Advisor to the House of Commons Select Committee on Science & Technology, Head of the Microbiology Group and Director of the Environmental Healthcare Unit. University of Southampton, UK, University of Southampton

  • Defining what VBNC bacteria are
  • Tools to identify VBNC bacteria and biofilms
  • When disinfectants or sanitizers mislead
  • Animal models to confirm VBNC infectivity
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    18:00

    Chairman's Closing Remarks and Close of Day One

    Olivier Chancel, Sterility and Aseptic Process Assurance Expert, Boehringer Ingelheim

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    James Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

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    9:10

    Mycoplasma safety testing of biopharmaceuticals and ATMPs by rapid NAT-based detections methods – Current regulations, challenges and trends

    Renate Rosengarten, Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna

  • Why do mycoplasmas pose such a challenge in implementing safety concepts for biopharmaceuticals and ATMPs
  • Haemoplasmas as potential contaminants of ATMPs
  • A risk-based approach for the validation and implementation of rapid NAT-based mycoplasma safety testing
  • How to tailor a product-specific mycoplasma NAT method validation study to meet the regulatory requirement
     
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    9:50

    Risk mitigation strategies for animal-derived raw materials

    Rosemary Versteegen, CEO, International Serum Industry Association

  • Risk mitigation in sourcing
  • Does geography matter?
  • Where did that serum come from?
  • Robust viral clearance steps
  • Overview of options
  • Review of what works and why

     

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    10:30

    Morning Coffee

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    11:00

    Innovative sampling strategies to retrieve the invisible

    Sonia Allibardi, Market Access Manager, Copan Italia SpA

  • What swab to use for surface monitoring of environmental microbial contamination?
  • The hidden technology of COPAN FLOQSwabs®
  • Innovative approaches for sampling
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    11:40

    Current and Novel Viral Safety Strategies Applied to the Manufacture of Plasma-Derived Medicinal Products (PDMPs)

    Steve Simoneau , Biological Safety Project Manager, The LFB Group

  • Current challenges and methods of adventitious agent clearance
  • Novel strategies for safeguarding patients
    1. Quality by Design (DoE approach)

    2. Next Generation Sequencing

       

       

       

     

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    12:20

    Definition of the Limit Of Detection (LOD) of the Human Eye for Environmental Monitoring (EM) plate reading

    Laurent LeBlanc, R&D Healthcare Culture Media Manager, Biomerieux

  • Design of a multiparametric model to assess the human eye LOD
  • Presentation of the results with a statistical analysis of the data
  • at the plate level, i.e. Presence / Absence of contamination
  • at the colony levels, i.e. False Positive / False Negative detections rates
  • Presentation of a further study based on Pharmacopoeia incubation standards

     

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    13:00

    Networking Lunch

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    14:10

    Real time microbial detection – Process control and implementation of online microbial monitoring for pharmaceutical waters

    James Cannon, Head of OEM and Markets, Mettler-Toledo Thornton

  • Review of Pharmacopeia and Regulatory positions on adoption of alternative microbial methods
  • Current state of real time microbial detection technology
  • Case study of implementation of online microbial monitoring in a Global Pharmaceutical facility
  • Guidance for evaluation and establishment of new microbial limits
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    14:50

    Influence of temperature of incubation on results of microbiological environmental monitoring

    Philippe Dutot, Sterility Assurance Specialist, Novo Nordisk

  • Regulatory perspective
  • Bibliography review focused on “in situ” studies
  • Results of a one-year comparison study between two incubation regimens (30-35°C for 3 days vs 20-25°C for 5 days) for the monitoring of a pharmaceutical production classified area
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    15:30

    Afternoon Tea

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    16:00

    Return of experience on implementation of mycoplasma alternative method to release vaccines

    Marine Marius, Scientist, Analytical Research and Development Europe, Sanofi Pasteur

  • Implementation of a Rapid Microbial Method for mycoplasma testing
  • Journey of an investigational vaccine
  • Journey of a legacy product
  • Return of experience
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    16:40

    Future of endotoxin testing in pharmaceutical industries

    Thierry Bonnevay, Microbiology Platform Head Analytical Research & Development, Sanofi Pasteur

  • Trends in endotoxin testing
  • Evaluation and implementation of new methods
  • Results of an internal evaluation
  • What’s next?
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    17:20

    Chairman's Closing Remarks and Close of Day Two

    James Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society


    Vice President, Head of Competence Center Microbiology and Aseptic Techniques
    Fresenius Kabi
    Scientific Advisor to the House of Commons Select Committee on Science & Technology, Head of the Microbiology Group and Director of the Environmental Healthcare Unit. University of Southampton, UK
    University of Southampton
    Senior Manager, Team Leader, Vaccines Quality Audit
    GSK
    Chairman
    Pharmaceutical and Healthcare Sciences Society
    Head of OEM and Markets
    Mettler-Toledo Thornton
    Senior Technical Service Manager
    STERIS Corporation
    R&D Healthcare Culture Media Manager
    Biomerieux
    Scientist, Analytical Research and Development Europe
    Sanofi Pasteur
    Contamination Control and Cleanroom Expert
    Microrite, Inc.
    Sterility and Aseptic Process Assurance Expert
    Boehringer Ingelheim
    Sterility Assurance Specialist
    Novo Nordisk
    Professor and Chair of Bacteriology and Hygiene
    University of Veterinary Medicine Vienna
    CEO
    International Serum Industry Association
    Market Access Manager
    Copan Italia SpA
    Biological Safety Project Manager
    The LFB Group
    Microbiology Platform Head Analytical Research & Development
    Sanofi Pasteur
    Regulatory Affairs Director Europe, Middle East and Africa
    Dupont De Nemours (Luxembourg) S A
    Sterile Manufacturing Specialist
    AstraZeneca
    Founder and CEO
    Microrite

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    Workshops

    Pharmaceutical Microbiology 2019 Attendees

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    Pharmaceutical Microbiology - Speaker Interview Marine Marius

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    Pharmaceutical Microbiology - Speaker Interview Thierry Bonnevay

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    Pharmaceutical Microbiology - Speaker Interview Dr Alexander Stoll

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    Pharmaceutical Microbiology - Speaker Interview Philippe Dutot

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    Pharmaceutical Microbiology 2019 Workshops

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    Pharmaceutical Microbiology 2019 Full Programme & Speakers

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    Pharmaceutical Microbiology 2019 Programme At A Glance

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    Pharmaceutical Microbiology 2019 Brochure

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    Janssen - Past Presentation 2018

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    Boehringer Ingelheim - Past Presentation 2018

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    MHRA - Past Presentation 2017

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    Biomerieux - Past Presentation 2018

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    Alexion - Past Presentation 2017

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    STERIS - Past Presentation 2018

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    Charles River Laboratories - Past Presentation 2018

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    Sponsors and Exhibitors


    DuPont

    Gold Sponsor
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    DuPont Personal Protection provides a wide range of personal protection solutions including some of the most trusted and innovative brands in the industry, such as Tyvek®, Tyvek® IsoClean®, Tychem® and ProShield® to meet your safety and Controlled Environment needs. Tyvek® IsoClean® products are specially designed for controlled environments that require high standards for particle and microbiological contamination control. This comprehensive selection of solutions is designed for use in pharmaceutical, medical device, biotech and electronic settings. For more visit: www.tyvek.co.uk/isoclean

    Sponsors and Exhibitors


    bioMérieux

    Sponsors and Exhibitors
    http://www.biomerieux.com/en/industry-solutions

    A world leader in the field of in vitro diagnostics for over 50 years, bioMérieux is present in more than 150 countries through 43 subsidiaries and a large network of distributors. In 2017, revenues reached €2.3 billion, with over 90% of sales outside of France. bioMérieux provides diagnostic solutions (systems, reagents, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.


    COPAN

    Sponsors and Exhibitors
    http://www.copangroup.com

    With a rightful reputation for innovation, COPAN is the world leading manufacturer of collection and transport systems. In like manner, COPAN’s collaborative approach to pre-analytics has resulted in the development of FLOQSwabs®, ESwab®, UTM® and modular laboratory automation, WASP® and WASPLab®. For further information on COPAN, visit www.copangroup.com


    Fujifilm Wako

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    http://www.wakopyrostar.com

    Long recognized as a world-renowned supplier of high purity chemicals, Fujifilm Wako has dedicated more than 30 years of research and development to providing innovative endotoxin-specific reagents and consumables for “every user and for every method”. Visit us at www.wakopyrostar.com to learn how Fujifilm Wako can best support your quality testing needs.


    RSSL

    Sponsors and Exhibitors
    http://www.rssl.com

    Reading Scientific Services Limited (RSSL) provides analytical, investigational, consultancy and training services to clients in the global pharmaceutical, biopharmaceutical and healthcare industries. We help our partners to develop drug products that are safe, innovative and of the highest quality.

    Our GMP compliant facilities are located in the UK and with our team of more than 200 dedicated scientists we ensure that every project is performed with our absolute commitment to outstanding quality, scientific excellence and customer satisfaction.

    We offer a large portfolio of microbiological, biological, chemical and physical services to ensure the identity, purity, safety and quality of your product through the full drug product life cycle.

    Our comprehensive range of services include:

    • - Microbial Limits testing (EP, BP, USP, CP and JP)
    • - Quantitative Endotoxin Analysis
    • - Preserative Efficacy Testing
    • - Water Testing
    • - Extractables and leachables studies
    • - GMP Batch Release
    • - Stability Studies
    • - Method development and validation
    • - Physical and Structural Characterisation
    • - Contamination identification and troubleshooting
    • - Regulatory and compliance training
    • - Consultancy

    Media Partners


    Genetic Engineering News

    Official Media Partner
    http://www.genengnews.com

    Genetic Engineering & Biotechnology News (GEN) is the most authoritative and widely read biotechnology news publication in the world.Published 21 times a year,GEN's unique news and technology focus include the entire bioproduct life cycle from early-stage R&D to applied research and bioprocess through to commercialization. GEN is the only publication that provides the full range of the biotechnology market coverage in areas such as omics, drugs and biomarker discovery, bioprocessing, clinical research, molecular diagnostics and biobusiness. For a free subscription go to: http://www.genengnews.com/subscriptions.aspx


    Microbiology Society

    Official Media Partner
    http://www.microbiologysociety.org

    The Microbiology Society is a membership charity for scientists interested in microbes, their effects and their practical uses. It is one of the largest microbiology societies in Europe with a worldwide membership based in universities, industry, hospitals, research institutes and schools. Our members have a unique depth and breadth of knowledge about the discipline. The Society’s role is to help unlock and harness the potential of that knowledge.


    European Pharmaceutical Review

    Official Media Partner
    https://www.europeanpharmaceuticalreview.com/

    European Pharmaceutical Contractor (EPC) is a quarterly publication dedicated to the international pharmaceutical contract market. Since its establishment in 1997, EPC has provided coverage of technical, strategic and regulatory developments within the industry. The magazine features in-depth opinion-led articles, reviews and interviews, on topics including drug development, outsourcing, pharmacovigilance, partnerships and eClinical management. Read EPC in print, online, or via the Samedan app.

    Media Partners


    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Samedan

    Supporters
    http://www.samedanltd.com/magazine/13.

    International Clinical Trials (ICT) is a quarterly magazine edited by Dr Graham Hughes, and written by specialists at the forefront of clinical research. ICT’s coverage of operational developments ranges from adaptive designs in early phase trials through to post marketing research. ICT’s targeted readership consists of key decision makers across the pharmaceutical and biotech industries, along with contract partners and consultants. The magazine is distributed to pharmaceutical professionals in Europe and North America, and is accessed globally online. Read the latest issues, explore the ICT archive and subscribe at www.samedanltd.com/magazine/13.


    MedTube

    Supporters
    https://medtube.net/



    Open Chemistry

    Supporters
    http://www.openchemistry.com

    Open Chemistry (IF - 1.425) is a peer-reviewed, open access journal that publishes original research, reviews and short communications in the fields of chemistry in an ongoing way. Our central goal is to provide a hub for researchers working across all subjects to present their discoveries, and to be a forum for the discussion of the important issues in the field.


    CanBiotech

    Supporters
    http://www.canbiotech.com

    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


    Pharmaceutical Technology

    Supporters
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Bentham Science

    Supporters
    http://www.benthamscience.com/

    Bentham Science Publishers is a major STM journal publisher of 130 plus print and online journal. Out of these, 40 journals have already registered good IMPACT FACTORS as per Journal Citation Reports® 2017. These titles have extensive readership mostly in Europe and North America. For a detailed profile please visit our website at http://www.benthamscience.com. Besides, Bentham Science publishes eBooks in all areas of Science, Technology and Medicine. Our eBooks provide professionals, academicians, corporate researchers, graduates and undergraduates worldwide with the most current information in their subject areas of interest. Our eBooks are also available in the ePub and Kindle formats besides the PDF edition here http://ebooks.benthamscience.com/. Bentham is offering attendees of this conference discounts on its publication. For more information click here


    Farmavita

    Supporters
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    SciDoc Publishers

    Supporters
    http://www.scidoc.org

    SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    World Pharma News

    Supporters
    http://www.worldpharmanews.com/



    Contract Biotechnology

    Supporters
    http://www.contract-biotechnology.com

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.


    Drug Target Review

    Supporters
    http://www.drugtargetreview.com

    Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


    IPI

    Supporters
    http://www.ipimediaworld.com

    IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


    Drug Development Technology

    Supporters
    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


    Pharmavision

    Supporters
    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    Mednous

    Supporters
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    American Pharmaceutical Review

    Supporters
    http://www.americanpharmaceuticalreview.com

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
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