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SAE Media Group’s 6th Annual Conference
Pharmaceutical Microbiology USA
April 26-27 2023 | Boston, USA

Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardize product batches.

 

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. The regulatory landscape is changing, firstly with the preparation of Annex I, in addition to increasing requirements pertaining to data integrity. Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.


On top of this, the developing integration of automation and robotics into the manufacturing pipeline, as well as the increased need for more rapid microbiology methods brought about in part by the surge in ATMPs, are all highlighting the necessity of the field in Pharma.
This industry is ever expanding -- join leading experts in 2023 to discuss and analyse the latest advances and challenges surrounding Pharmaceutical Microbiology. Network with industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insight into this corner of the field.
 

  • EXPLORE innovative contamination control strategies for cell & gene therapies and personalised medicines to ensure product quality and patient safety
  • REVIEW case studies on the implementation and validation of modern, rapid microbial testing methods for effective quality by design
  • EMPLOY effective contamination control in your manufacturing facility by benchmarking strategies with representatives from Boehringer Ingelheim, Takeda and GSK
  • LEARN how to control, identify and disinfect cases of mold contamination and ensure your disinfectant programme meets regulatory expectations
  • DELVE into the role of microbiologists in combination product manufacturing and how parametric release and holistic closure integrity testing can ensure a contaminant free product

<p>Heads of Aseptic Processing <br /> Heads of Microbiology <br /> Global Quality Directors <br /> Heads of GMP Compliance <br /> Quality &amp; Compliance Heads <br /> Microbiology Senior Specialists <br /> Directors of Quality Control Biology <br /> Quality Control Managers <br /> Quality Assurance Managers <br /> Lean Managers <br /> Operations Managers <br /> Heads of Site Compliance <br /> Heads of Sterile Technology <br /> Global Microbiology Analytical Experts <br /> Cleanroom Managers <br /> Regulatory Affairs Managers <br /> Production Managers <br /> Quality Systems Managers<br /> &nbsp;</p> <p>Previous attendees include:<br /> &nbsp;</p>

<p>Associates of Cape Cod; Association of Cape Cod, Inc; Bioscience International; Boehringer Ingelheim; Boehringer Ingelheim Pharma GmbH &amp; Co. KG; Boehringer Ingelheim Pharma GmbH &amp; Co.KG; Boehringer Ingelheim Promeco SA de CV; Bristol Myers Squibb; Cleaning Validation, North America; Ecolab; Eli Lilly and Company; Eli Lilly Italia; Eli Lilly Italia SpA; FDA; Genentech; GSK; Merck; Merck &amp; Co, Inc; Merck &amp; Co.; Merck and Company Inc.; Mettler Toledo; Microbiologics; MSD; Office of Pharmaceutical Manufacturing Assessment / FDA; Organogenesis Inc; Parexel International; PDA Japan Chapter; Pfizer; Regeneron Pharmaceuticals Inc.; Sanofi; SmartLabs; STERIS Corporation; STERIS Laboratories; Sun Pharma Inc; Takeda; Takeda Pharmaceuticals; U.S. Food and Drug Administration; Vericel Corporation;</p>

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

9:10 Considerations for the implementation of modern technologies for Pharmaceutical Microbiology

Donald Singer

Donald Singer, USP General Chapter Committee Microbiology Chair, US Pharmacopeia
View Bio

  • The current state of play for the integration of alternative microbial methods
  • Identifying where new technology can be incorporated into the manufacturing programme
  • Robotics and automation a gold standard in contamination control 
  • Future Considerations- where is Pharmaceutical Microbiology heading
  • 9:50 Employing an Environmental Monitoring Performance Qualifications in new facilities: A harmonized risk-based approach to Environmental Monitoring from BioPhorum

    Hilary Chan

    Hilary Chan, Principal Quality Control Scientist, Takeda
    View Bio

  • Understanding classified environments for the aseptic manufacturing of sterile drug substances and drug products require strict control to minimize the potential for microbiological and particulate contamination of the product
  • A six factor-based policy to assess the possibility of contamination in a risk-based framework
  • Recommendations on the frequency of sampling and methods of sampling when defining an initial EMPQ
  • Implementing the guidance when with practical illustrative examples from Grade A-C
     
  • 10:30 Morning Coffee

    11:00 Validating and implementing modern microbiological methods

    Laurie Boyd

    Laurie Boyd, Senior Microbiologist/Team Leader, Alkermes, Inc.
    View Bio

  • Understanding the need for rapid but accurate microbiological methods in microbiology lab
  • How does regulatory and compliance requirements are pushing for recombinant technology
  • Online water bioburden testing and automated testing for RT product release 
  • How data integrity challenges are amplifying the problems with implementation 
  • 11:40 Growth Modelling of Aseptic Process Simulation Contamination Events

    Austin Kuo

    Austin Kuo, Senior Director - Sterility Assurance - TS/MS, Eli Lilly
    View Bio

  • Exploring methods and benefits of performing mathematical modelling of microbiological growth when investigating aseptic process simulation (APS) contamination events
  • Transforming APS contamination patterns into explainable inherent behaviours of microbes
  • Case studies of growth modeming being utilized to predict / confirm the failure mode resulting in the contamination events
  • 12:20 Preparing for the QC Lab of the Future

    Shelton Sparks

    Shelton Sparks, Product Manager Testing Solutions, Lonza
    View Bio

  • Implement QC testing tools for Pharma 4.0 and Pharma 5.0
  • Streamline testing workflows with integrated lab automation 
  • Error-proof bacterial endotoxin testing
  • Reduce laboratory disruptions with assay versatility
  • 12:50 Networking Lunch

    13:50 Disinfectant Field Trial that Meets Annex I Guidance

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, Steris Corporation
    View Bio

  •  Key components of CCS will be covered relating to a disinfectant field trial
  • A Case Study utilizing a quaternary ammonium and hydrogen peroxide/peracetic acid technology will be covered
  • Material flow, Engineering controls, utility supplies and operational procedures will be covered
  • Field trial environmental monitoring test data will be discussed from the Biopharma case study
     
  • 14:30 Importance of Microbiological Standards for pharmaceutical compounding

    Jason  McGuire

    Jason McGuire, Vice President, Global Quality, Fagron
    View Bio

  • Reviewing the current trends and practices in US
  • Implementation of alternative microbiological methods and innovative technologies 
  • Review of new guidance’s, guidelines, and regulatory enforcement activities
  • A look into the future of global personalized medicine
     
  • 15:10 Afternoon Tea

    15:40 Optimising the release of Cell Therapies with FDA approved rapid

    John Duguid

    John Duguid, Executive Director, Research & Development, Vericel Corporation
    View Bio

  • Understanding why same day product release is needed for ATMP therapeutics
  • Maximising the use of automated rapid microbiological methods enable test results within hours
  • How the regulatory requirements are continuing to evolve to improve product release
  • 16:20 Case study on using contamination recovery rates to measure performance and improve

    Li Wei Chan

    Li Wei Chan, Manager Microbiology, MSD Pharma (Singapore) Pte Ltd

  • 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
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    9:10 Design of a Global Sterility Assurance Program

    Liz Brockson

    Liz Brockson, Aseptic Processing and Sterility Assurance Lead, Takeda

  • Development of a network wide program to enhance sterility assurance for sterile production sites and aseptic practices for low bioburden manufacturing sites
  • On-site collaboration to support standardization, harmonization and implementation of best practices across sterile manufacturing sites
  • Training & capability building on aseptic practices and sterility assurance throughout the network
  • 9:50 Implementing a Contamination Control Strategy

    Alison Laughlin

    Alison Laughlin, Associate Director, Regional Quality NA & Sterility Process Assurance, Boehringer Ingelheim

  • Elements of a Robust Contamination Control Strategy
  • Best Practices for Implementing a Contamination Control Strategy
  • Documenting the Contamination Control Strategy
  • Determining the effectiveness of the contamination control strategy
  • The Benefits of a Well-Defined Contamination Control Strategy
  • 10:30 Morning Coffee

    11:00 Practical applications for the introduction of effective Contamination Control Strategies

    11:40 Overcoming the challenges with sterility assurance assessment

    John Arigo

    John Arigo, Division Director, FDA

  • Introduction to FDA guidance on Pharmaceutical Manufacturing and Microbiology
  • Understanding where common errors lie in regulatory applications
  • Recommendations on quick and successful applications
     
  • 12:20 Networking Lunch

    13:20 Optimising recovery post-mold contamination from investigation to start-up

    Gurpreet Ganda

    Gurpreet Ganda, Senior Manager, QC Microbiology, Roche

  • Understanding mold classes, spore patterns and differentiation from sub-types
  • Strengthening the investigation into mold contaminations in Grade A facilities
  • Developing a contamination control strategy with mold prevention in mind
  • Overcoming infection with strategic cleaning and disinfection
  • 14:00 Parametric Release for Products Terminally Sterilized with Moist Heat: A Call to Action

    Kenneth Paddock

    Kenneth Paddock, Quality Director, Sterility Assurance, Baxter

  • Review of Status of Parametric Release for Products Terminally Sterilized on challenges to the implementation of Parametric Release
  • The impact of the TR 30 and Annex 17 for Parametric Release
  • Develop action items to reduce the industry over reliance on the test for sterility by increasing the implementation of Parametric Release
  • RTRT- Is PR the driving force behind RTRT?
  • 14:40 Afternoon Tea

    15:10 Developing multidose preservative-free container closure systems to meet regulatory requirements

    Erika Pfeiler

    Erika Pfeiler, Branch Chief, FDA

  •  The FDA’s current outlook on container closure systems with a look to the future of testing and development 
  • Optimizing method development for CCCT throughout the product lifecycle
  •  Maximising validation and regulatory compliance and through understandings of USP 1207.1
  •  Best practises for sterility assurance for combination products
  • 15:50 Improving Container Control Integrity Testing with a deep dive on testing methods

    Michael Song

    Michael Song, Associate Director, Takeda Pharmaceuticals

  • Developing a holistic container closure integrity (CCI) strategy from component level through manufacturing to finish
  • Strategic approaches to picking the best CCI test from Vacuum Decay to HGA
  • Optimising CCIT for medical devices and combination products
  • Improving the effectiveness of your contamination control strategy with validated CCIT
     
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Alison Laughlin

    Alison Laughlin

    Associate Director, Regional Quality NA & Sterility Process Assurance, Boehringer Ingelheim
    Austin Kuo

    Austin Kuo

    Senior Director - Sterility Assurance - TS/MS, Eli Lilly
    Donald Singer

    Donald Singer

    USP General Chapter Committee Microbiology Chair, US Pharmacopeia
    Erika Pfeiler

    Erika Pfeiler

    Branch Chief, FDA
    Gurpreet Ganda

    Gurpreet Ganda

    Senior Manager, QC Microbiology, Roche
    Jason  McGuire

    Jason McGuire

    Vice President, Global Quality, Fagron
    Jim Polarine

    Jim Polarine

    Senior Technical Service Manager, Steris Corporation
    John Arigo

    John Arigo

    Division Director, FDA
    John Duguid

    John Duguid

    Executive Director, Research & Development, Vericel Corporation
    Michael Song

    Michael Song

    Associate Director, Takeda Pharmaceuticals
    Shelton Sparks

    Shelton Sparks

    Product Manager Testing Solutions, Lonza

    Alison Laughlin

    Associate Director, Regional Quality NA & Sterility Process Assurance, Boehringer Ingelheim
    Alison Laughlin

    Austin Kuo

    Senior Director - Sterility Assurance - TS/MS, Eli Lilly
    Austin Kuo

    Mr. Kuo earned a Masters in Microbiology from Michigan State University and brings over 20 years of experience in parenteral manufacturing, with a focus on sterility assurance and environmental monitoring programs. He has led Quality and Technical Services organizations supporting environmental monitoring, aseptic process simulations (media fills), aseptic technique, personnel gowning and hygiene, aseptic interventions, sterile filtration validation, sanitization programs and agent validation, and sterility assurance risk assessments supporting parenteral operations.

    Donald Singer

    USP General Chapter Committee Microbiology Chair, US Pharmacopeia
    Donald Singer

    Don Singer is Senior Microbiology Technical Consultant, North America, for Ecolab, and a Fellow in the American Society for Quality. He was formerly a GSK Senior Fellow. Don is currently Chair of the USP General Chapters - Microbiology Committee of Experts and has been a member since 2000. He is a Certified GMP Professional, a Certified Specialist Microbiologist and is a member of the European Pharmacopeia Group 1 Microbiology Committee. Don is also an adjunct professor in the Biopharmaceutical Quality graduate program at the University of Maryland Baltimore County. He was an author of the PDA Technical Report for “Contamination Control Strategy” along with two other technical reports, one for Pharmaceutical Package Integrity and one for Objectionable Microorganisms. Don’s career spans over 40 years of research and quality control.

    Erika Pfeiler

    Branch Chief, FDA
    Erika Pfeiler

    Gurpreet Ganda

    Senior Manager, QC Microbiology, Roche
    Gurpreet Ganda

    Hilary Chan

    Principal Quality Control Scientist, Takeda
    Hilary Chan

    Hilary Chan is a Principal Quality Control Scientist in Global Microbiology Management at Takeda and is based out of Lexington, MA. In her current role, Hilary is responsible for leading various technical improvement initiatives related to microbiological issues/contamination control for Takeda’s global manufacturing operations. She is a business process owner for environmental monitoring as well as a contamination control community of practice network lead for Takeda. She is an invited speaker at industry conferences and has authored various scientific publications. Hilary has over 20 years of experience in the biotech industry and holds a Bachelor’s degree in Zoology from Colorado State University and a Master’s degree in Biomedical Science from Northeastern University.

    Hilary Chan

    Principal Quality Control Scientist, Takeda
    Hilary Chan

    Jason McGuire

    Vice President, Global Quality, Fagron
    Jason  McGuire

    Jason has spent nearly 20 years in the health care industry serving in many roles with a particular focus on Quality control operations, Quality assurance and regulatory support. He’s a microbiologist by education and expertise, spending 2 years on the bench developing anaerobic microbial catalysts for fuel ethanol production. For the last 15 years, he has worked with non-sterile and sterile compounding facilities, national health systems, medical device, biotechnology and pharmaceutical companies helping them troubleshoot and bringing resolution to complex challenges.

    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 twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. 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 on the PDA’s COVID-19 Task Force and the PDA’s Microbial Excursions Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators with FDA, MHRA, HPRA, ANVISA, and ANMAT as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the 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.

    John Arigo

    Division Director, FDA
    John Arigo

    John Duguid

    Executive Director, Research & Development, Vericel Corporation
    John Duguid

    JOHN DUGUID is Senior Director, Research & Development at Vericel Corporation. As
    a Principal Scientist at Genzyme, he was responsible for developing and implementing
    rapid microbiological assays and had previously managed QC cell therapy operations.
    Prior to Genzyme, he worked as an analytical chemist at Abbott Laboratories and Arthur
    D. Little. Mr. Duguid received his BS in Chemistry from the University of Michigan

    Kenneth Paddock

    Quality Director, Sterility Assurance, Baxter
    Kenneth Paddock

    Kim Sobien

    Contamination Control Lead:, GSK
    Kim Sobien

    Laurie Boyd

    Senior Microbiologist/Team Leader, Alkermes, Inc.
    Laurie Boyd


    I received my undergraduate degree from Bowling Green State University in Biology and my graduate degree in Business Management from The University of Phoenix. I have worked in the Pharmaceutical industry as a Quality Control Microbiologist and Chemist for 20 years. I have worked for Pharmacia and Upjohn, Pfizer and Alkermes. I have a background in Sterile and Non –sterile manufacturing which include Biologics, Orals, API and Injectables.
     

    Li Wei Chan

    Manager Microbiology, MSD Pharma (Singapore) Pte Ltd
    Li Wei Chan

    Liz Brockson

    Aseptic Processing and Sterility Assurance Lead, Takeda
    Liz Brockson

    Michael Song

    Associate Director, Takeda Pharmaceuticals
    Michael Song

    Shelton Sparks

    Product Manager Testing Solutions, Lonza
    Shelton Sparks

    Shelton Sparks, product manager for Lonza Testing Solutions, supports the endotoxin detection portfolio. Following management of Lonza’s PyroGene® rFC Assay and instrumentation, Shelton now focuses on the PyroTec® PRO Automated Endotoxin Testing System and WinKQCL® Software solutions that help customers error-proof and future-proof their QC testing programs. He joined Lonza in 2017 as a research engineer before transitioning into his current role. Shelton has a BS in Chemical Engineering from the University of Alabama and is currently pursuing a MBA from Lehigh University.

     

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    Past Attendees List

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    Full Agenda

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    Chair Letter

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    Speaker Biographies

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    Short Agenda

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    Sponsors


    Lonza

    Sponsors
    http://bioscience.lonza.com

    Lonza is the trusted QC testing solution provider for the pharmaceutical and medical device industries. Lonza offers fully integrated software solutions and products for quantitative endotoxin detection, whether traditional, sustainable or automated methods are needed. Lonza transforms its practical knowledge and technical expertise to deliver a portfolio of endotoxin detection products and paperless QC microbiology, software and services that support the critical needs of regulated manufacturing environments.

    Exhibitors


    Bioscience International

    Exhibitors
    http://www.biosci-intl.com

    The newest generation of SAS microbial air monitors, for ensuring full compliance with ISO 14698, cGMP and other international monitoring guidelines will be displayed.


    Ecolab

    Exhibitors
    https://en-uk.ecolab.com/

    Ecolab’s Life Sciences division is dedicated to developing the best possible products and services to support our customers in the pharmaceutical industry.

    Our comprehensive solutions and technical expertise are focused on cleaning, sanitisation and contamination control, all while ensuring safety, compliance and operational efficiency.


    Media Partners


    American Pharmaceutical Review

    Official Media Partner
    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


    Labcompare

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    http://www.labcompare.com

    Labcompare is a product of American Laboratory, and is already included in the AL logo on your website. I have attached the standalone Labcompare logo and info is below, but if you do add this one separately, could you exchange the American Lab logo with the one attached? For laboratory managers and researcher scientists across analytical chemistry and applied sciences who need to find product solutions, advice, and access scientific tools. Labcompare provides an industry-leading, comprehensive, online resource of product information to support the laboratory’s needs. Labcompare supports every step of the buying journey by focusing on core and new product technology, supplies, tips, and buyer’s guides.


    Rapid Microbiology.com

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

    rapidmicrobiology.com is a well-established on-line resource for microbiologists worldwide, find the right products for your microbiology lab using our specially designed search functions. To keep up-to-date with the latest microbiology news get our free weekly newsletter which includes updates on products, services, webinars, training courses and conferences.


    Medical Design Briefs

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    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/SMIEAST21

    Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.

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    pharmaphorum

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    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


    BioChem Adda

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    BioChem Adda is a Not-just-for-Profit organization which aims to bring out the most reliable and transparent information about everything related to jobs, careers, education, news, articles, and events from the field of BioSciences and Chemistry!


    Biocompare

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    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.


    SelectScience

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    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover the latest drug discovery and development technologies, products and techniques with product reviews, videos, application notes and news articles. Become a member for free today.


    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.


    IBI - International Biopharmaceutical Industry

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    http://www.biopharmaceuticalmedia.com

    IBI - International Biopharmaceutical Industry, provides the biopharmaceutical industry with comprehensive coverage of key scientific, technology, regulatory and business topics. The editorial mix of peer-reviewed papers, practical advice on managing bioprocessing and technology, regulatory and business columns, and expert commentary provides comprehensive coverage of upstream and downstream processing, manufacturing operations, regulations, formulation, scale-up/technology transfer, drug delivery, analytical testing and more. The insight and analysis covers biologic – based therapies including We will report on emerging trends, strategies and best practices in the key areas.


    Technology Networks

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    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Drug Discovery Today

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    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.


    Genetic Engineering News

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    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


    Pharma Journalist

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    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    Contract Biotechnology

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    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.

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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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    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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