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SAE Media Group’s 16th Annual Conference

Parallel Trade

21-22 March, 2022 | Conference
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SAE Media Group presents its 16th annual Parallel Trade conference on the 21st and the 22nd March 2022. As the only parallel trade conference in Europe, this event provides the perfect platform for industry experts from both sides of the coin to come together and share perspectives on the practice of parallel trade.

The 2022 event will be more significant than ever before due to the transition period follow Brexit now also coming to an end. As such, the UK will no longer be part of the EU free market. This will mean increased medicines prices, reduced access to some specialist drugs and greater risk of supply chain shortages. In a post-Brexit environment, exhaustion of rights will cease to apply to the UK, making import and export a costly business and in a worst-case scenario could effectively kill parallel distribution.

This conference will bring together industry experts to discuss the challenges and drivers of the industry, including the EU regulatory landscape and the impact of the Brexit and the Pandemic together. The conference will also provide global insights on Parallel trade and will reflect on key takeaways for other member states.

pbaynham@SAE Media Group-online.co.uk

  • Discover the impact of Covid-19 on Parallel trade as countries begin to release restrictions. How has the sector been influenced?
  • Engage in discussions on the growth within parallel trade over the past year at the only Parallel Trade specific conference within the EU.
  • Discuss the impact on UK parallel trade following Brexit, through the eyes of regulators, the pharmaceutical industry and academics
  • Develop further understanding of the rules and regulation changes over the past 12 months, Parallel Trade, where are we now?

Vice President/ Heads of/General Managers:
• International Trade and Relations
• Supply Chain Development – Brexit
• Brexit Implementation
• Market Access
• Supply Chain Manager
• Parallel trade reporting
• Regulatory Affairs
• IP
• Purchasing
• Policy Patent Operations
• European Affairs
• Supply and Demand
• Attorney
• Distribution

 

AbbVie; AIFA - Agenzia Italiana Del Farmaco; Amgen Europe BV; Arnold & Porter; Baker & Mckenzie; bij CyTuVax b.v. ; Bristows LLC; Covington & Burling; Daiichi Sankyo Europe GmbH; Department of Health and Social Care; EAEPC; Erasmus University Rotterdam; Europe Economics; European Alliance for Access to Safe Medicines; European Association of Euro-Pharmaceutical Companies ; Ferring Pharmaceuticals; FERRING SA; Freshfields Bruckhaus Deringer LLP; Gilead Sciences Ltd; Hollister Europe Ltd; Intellectual Property Office; IQVIA; IQVIA Commercial GmbH & Co. OHG; Key Pharmaceuticals Ltd; Kopinke; LEO Pharma; Lisman Legal Life sciences B.V.; Medac GmbH; MHRA; MSD Animal Health ; Mundipharma; Novartis Pharma AG; Novartis Pharmaceuticals UK Ltd; Novo Nordisk Bioindustrie Sa; Novo Nordisk Ltd; SoftGroupáLtd.; UEA, University of East Anglia; White & Case LLP; Wiggin LLP; Windt Le Grand Leeuwenburgh;
 

Conference programme

8:00 Registration and Coffee

9:00 Chair's Opening Remarks

Eric Noehrenberg

Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym
View Bio

Christopher Stothers

Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP
View Bio

9:10 The trading of in-vitro-medical devices

Ulf Grundmann

Ulf Grundmann, Partner, King & Spalding LLP
View Bio

• An overview of the new EU regulation on medical devices
• The additional requirements to be met by parallel traders moving forward
• Case study related to the legal case of ‘Servoprax’
• Next steps for traders and manufacturers ahead of the IVD regulation change
 

9:50 Exhaustion of IP rights and Parallel Trade

• Parallel exports from the UK to the EEA
• Actions for parallel exporters of IP-protected goods
• Actions for IP rights holders
• Consultation on the UK’s future exhaustion of IP rights regime
 

Beatriz San Martin

Beatriz San Martin, Partner, Arnold & Porter
View Bio

Shishu Chen

Shishu Chen, Senior Associate, Arnold & Porter
View Bio

10:30 Morning Coffee

11:00 Key updates, including EU case law

Peter Bogaert

Peter Bogaert, Managing Partner, Covington & Burling LLP
View Bio

• Update on EU case law (including on safety features)
• Lessons learnt from the new veterinary medicines Regulation (applies as from January 2022)
• A general overview on the changes in regulations over the past year
• The importance of safety within parallel trade and what can be done to improve it?
 

11:40 An update on Parallel Trade in EE

Martin Slegl

Martin Slegl, General Manager Czech Republic and Slovakia, IQVIA
View Bio

• Main trends to be understood
• Access to innovation
• Selected case studies about parallel trade
 

12:20 Networking Lunch

13:20 De-branding and re-branding without the consent of the IP-owner

Paul Maeyaert

Paul Maeyaert, Partner, Fencer Law
View Bio

• Understanding the impact of de-branding and re-branding
• Obtaining consent from an IP owner
• The impact on IP rights holders from re-branding
• How does this effect parallel trade and the import of medicines

14:00 Latest key trends of Parallel Trade within Europe, Covid, Brexit and more…

Shabnam Hanassab

Shabnam Hanassab, Engagement Manager, IQVIA

• Latest and historical overview of Parallel Trade sales trends across the EU
• The impact of Brexit and COVID-19 on parallel trade
• Exploring the key drivers of Parallel Trade across Europe and latest examples
 

14:40 Regulatory, Economic and Market Evolution of PT

Fabrizio Gianfrate

Fabrizio Gianfrate, Professor of Health Economics, University of Ferrara and Rome
View Bio

• PT in a next unique EU HTA and assessment scenario development
• Impact and response of PT on public healthcare services
• Future scenarios of PT for manufacturer, wholesale, and pharmacists
• Possible win-win solutions
 

15:20 Afternoon Tea

15:50 Intellectual property and free movement of goods: the internal market in pharmaceuticals

Stefan Enchelmaier

Stefan Enchelmaier, Professor of European and Comparative Law, Tutor in Jurisprudence, Lincoln College, GB-Oxford
View Bio

• Territoriality of National IP Rights
• Key provisions of the relevant Directives and Regulations, and their relationship with the Treaty
• Exhaustion of the rights conferred by trademarks and patents
• When parallel trade is permissible, and when it is not
 

16:30 Panel Discussion: Understanding the impact of Parallel Trade, from production to sales

• The impact on wholesalers and pharmacists
• The working relationship between wholesalers and industry
• Manufacturing requirements and how this impacts sales
• What needs to change across the industry to improve customer safety
 

Eric Noehrenberg

Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym
View Bio

Fabrizio Gianfrate

Fabrizio Gianfrate, Professor of Health Economics, University of Ferrara and Rome
View Bio

Tushar Patel

Tushar Patel, Technical Director, Key Pharmaceuticals Ltd
View Bio

17:10 Chair's Closing Remarks and Close of Day One

Christopher Stothers

Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP
View Bio

Eric Noehrenberg

Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym
View Bio

8:30 Registration and Coffee

9:00 Chair's Opening Remarks

Eric Noehrenberg

Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym
View Bio

Christopher Stothers

Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP
View Bio

9:10 Parallel Trade post Brexit – Regulatory Insight

• Summary of the changes to the regulatory framework in the UK post Brexit and the position in Northern Ireland
• The effect of Brexit on UK and EU regulations, what considerations should companies be aware of?
• Overview of regulatory considerations and impact on EU case law on parallel trade in the UK
• How to ensure your business model/supply chain is fit for purpose
 

Jackie Mulryne

Jackie Mulryne, Partner, Arnold & Porter
View Bio

Libby Amos-Stone

Libby Amos-Stone, Counsel, Arnold & Porter
View Bio

9:50 Competition Law – An Update

Wes Lepla

Wes Lepla, Senior Associate, Covington & Burling
View Bio

• State of play in the EU
• Implications of Brexit
• Language in cooperation agreements
 

10:30 Morning Coffee

11:00 Parallel Trade after Brexit – from inside and outside the EEA

Martin Howe QC

Martin Howe QC, Queens Counsel, 8 New Square
View Bio

• Government consultation on Parallel Trade and Intellectual Property (govt response if available)
• Special considerations in pharmaceutical sector, inc trademark substitution
• Parallel imports and regulatory barriers – from EEA and from outside
• Parallel importation and services
 

11:40 Parallel Trade, Northern Ireland, and the UK

Robin Blaney

Robin Blaney, Partner, Covington & Burling
View Bio

• Interpretation of the Northern Irish protocol
• UK approach to parallel imports (into the UK).
• Understanding the changes and challenges
• The future of parallel trade within Northern Ireland and the UK
 

12:20 Networking Lunch

13:20 Novartis – Case study: alchemizing generic medicines into branded products in parallel trade

Jeroen Muyldermans

Jeroen Muyldermans, Partner, Fencer Law
View Bio

• Re-branding of generic versions by parallel importers into branded originator medicines is one of the hot topics currently keeping the pharmaceutical industry busy.
• Does the first affixing of the trade mark owner’s brand on the product constitute an act of use for which exhaustion does not apply, or does intra-community free movement of goods provides for a derogation to the exclusive right?
• Is re-branding justified to ensure effective market access or rather to secure an economical advantage?
• Case-law of national courts throughout the EU has been scarce and divergent
• Two preliminary referrals involving Novartis are currently pending before the CJEU (joined cases C-253/20 and C-254/20) and merit an in-depth case study.
 

14:00 Understanding the benefits of Parallel Trade

Eric Noehrenberg

Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym
View Bio

• Why is parallel trade needed? What are the benefits?
• The challenges currently faced between parallel trade and industry
• What does the future look like for Parallel Trade
 

14:30 Afternoon Tea

15:00 Parallel Trade from the perspective of Dr.Max Group

Hynek Valerian

Hynek Valerian, Group Parallel Trade Manager, Dr.Max Group
View Bio

• Dr.Max Group introduction
• Perspective of the pharmacy chain
• Implications for the Group’s wholesale
 

15:40 Chair's Closing Remarks and Close of Day Two

Eric Noehrenberg

Eric Noehrenberg, Vice President and Global Head of Market Access and Government Affairs, Corcym
View Bio

Christopher Stothers

Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP
View Bio

+

Partner
Arnold & Porter
Partner
Freshfields Bruckhaus Deringer LLP
Vice President and Global Head of Market Access and Government Affairs
Corcym
Professor of Health Economics
University of Ferrara and Rome
Group Parallel Trade Manager
Dr.Max Group
Partner
Arnold & Porter
Partner
Fencer Law
Counsel
Arnold & Porter
Queens Counsel
8 New Square
General Manager Czech Republic and Slovakia
IQVIA
Partner
Fencer Law
Managing Partner
Covington & Burling LLP
Partner
Covington & Burling
Engagement Manager
IQVIA
Senior Associate
Arnold & Porter
Professor of European and Comparative Law, Tutor in Jurisprudence
Lincoln College, GB-Oxford
Technical Director
Key Pharmaceuticals Ltd
Partner
King & Spalding LLP
Senior Associate
Covington & Burling

Supporters

Workshops

Parallel Trade, let’s talk details
Workshop

Parallel Trade, let’s talk details

Copthorne Tara Hotel
23 March 2022
London, United Kingdom

The Case Law of Parallel Imports
Workshop

The Case Law of Parallel Imports

Copthorne Tara Hotel
23 March 2022
London, United Kingdom

VENUE

Copthorne Tara Hotel

Scarsdale Place, Kensington, London, United Kingdom

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.

 

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
HOTEL BOOKING FORM

Interview with Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP

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Interview with Tushar Patel, Technical Director, Key Pharmaceuticals

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Preliminary Attendees 2022

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Speaker Interview - Peter Bogaert, Covington & Burling LLP

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Interview with Peter Bogaert, Partner, Covington & Burling LLP

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Conference Co-Chair Letter

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Chair & Speaker Biographies

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Workshop B Agenda

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Workshop A Agenda

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Past Attendees

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Parallel Trade Brochure 2022

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Past Presentation - Peter Bogaert, Covington

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Past Presentation - Dr. Eric Noehrenberg, NIPC

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Past Presentation - Jackie Mulryne, Arnold & Porter

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Past Presentation - Dr Christopher Stothers, Freshfields Bruckhaus Deringer LLP

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Media Partners


Mednous

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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


Pharmalicensing

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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.


Gate2Biotech

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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.


World Pharma Today

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Pharmaceutical Outsourcing

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http://www.pharmoutsourcing.com

Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


Pharmiweb

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http://www.pharmiweb.com

Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


Pharmacircle

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http://www.pharmacircle.com

PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


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.


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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.


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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.


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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!


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American Pharmaceutical Review

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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


ASD MEDIA

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Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
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The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

For more detailed information please contact with: ASD MEDIA
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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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