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The development and maintenance of products for the life sciences sector requires virtually permanent (and increasing) ongoing interactions with healthcare professionals.  This includes post-market clinical follow-up studies, pharmacovigilance, health technology assessments, reimbursement discussions and the development of new products.  As these needs grow in future, companies need to reconcile such demands with the draconian nature of the new Bribery Act- described as the FCPA on steroids. 

As reiterated by the recent multimillion dollar fines imposed on J&J, bribery allegations must be considered throughout the product lifecycle, and even in M&A transactions.  We will summarise the law and the interaction with the ABPI Code of Practice.  In addition, implications of the historic Memorandum of Understanding, published by the ABPI and PMCPA in consultation with the SFO, will also be discussed.

Benefits of attending this masterclass include:

  • A clear understanding of the new law and its impact on crucial areas of practice in the life sciences sector
  • A consideration of the new law on various agreements with healthcare professionals:  research agreements, collaboration agreement, clinical trial agreements, consultancy agreements, PMCFU agreement, pharmacoviligance arrangements, speaker agreements, educational grants and sponsorships. 
  • How to handle Bribery Act considerations in commercial agreements with non-HCPs and M&A transactions. 
  • A practical guide to structuring and implementing a compliance regime considering the requirements in the UK, Germany and the Netherlands.
  • Some practical "war stories" and scenarios

Who should attend?

Vice Presidents, Directors, Partners, Heads, Managers and Associates in:

•   Clinical Development and Liaison
•   Mergers and Acquisition
•   Alliances
•   Business Development
•   Venture Capital
•   Compliance
•   Finance
•   General Counsel
•   Corporate Counsel
•   Contract Administration

 

About your masterclass leaders:

Mr Alexander Denoon, Partner, Lawford Davies Denoon, London

Alex has both a science degree (human genetics) and a law degree. He qualified as a solicitor in 1995. Alex spent more than five years in-house, including as general counsel and company secretary of biopharmaceutical company Biotech Australia.  Alex’s 10 years in private practice has been at top ranked firms in Australia and England.  Alex advises in relation to the regulation of pharmaceuticals, medical devices and advanced therapy medicinal products.

Alex also advises clients in relation to the development of strategies for the protection, defence and commercialisation of intellectual property.  This involves the development of strategies and drafting a wide array of commercial agreements from licences to joint ventures.   Alex has a breadth of international experience structuring, negotiating and drafting commercial agreements.  Alex is widely published in a variety of legal, scientific and industry journals.  Alex also co-authored the chapter “Intellectual Property” in “The Law & Regulation of  Medicines” published by Oxford University Press in 2008.

 

Mr Erik Vollebregt, Partner, Axon Lawyers, Amsterdam

Erik is a lawyer specialised in EU legal issues relating to life sciences. He has wide experience in life sciences legislation and regulatory,
at EU and Dutch level. Eric was trained as intellectual property and competition lawyer. He has gained experience in contentious matters, commercial contracts, and transactional work at the Directorate-General for Competition of the European Commission. He has worked for three large international law firms. Erik is acknowledged by Chambers Europe for his work in intellectual property and life sciences. He has worked in Brussels for several years, and is fluent in Dutch, English, French, German, and Swedish.

Erik’s software and engineering family background urged him to specialise in regulatory intellectual property and legal work in the medical
technology industry. His clients range from the largest listed to the smallest startup companies. Erik is a prolific writer and publishes in life sciences legal and regulatory journals. He is an editor of the Dutch life sciences law and regulatory journal and author of the Dutch manual on misleading and comparative advertising law. Additionally, he has a weblog on legal and regulatory aspects of medical technology, Medicaldeviceslegal. He often lectures at international conferences.

His memberships include the Netherlands Biotech Industry Association (NIABA), the Dutch Association Pharmacy and Law (VFenR), the Dutch Association for Advertising Law (VvRr), and Regulatory Affairs Professional Society (RAPS).

 

Dr Mathias Klümper,Partner, Lützeler und Partner Rechtsanwälte, Hamburg

Mathias worked as a lawyer and core member of the industry group  "Healthcare, Life Sciences and Chemicals" at the Düsseldorf office of Clifford Chance from 2004 until 2008. He advised clients from the pharmaceutical, medical device and biotechnology industry in all regulatory matters. He focussed on advising clients on healthcare fraud and abuse prevention (business compliance) and the implementation of employee guidelines and processes.


He does not only know the perspective of a lawyer but did also get a comprehensive insight into the in-house perspective within two client secondments in the European legal department of an international medical device company in Switzerland and a German pharmaceutical  company. He is author of a number of publications on regulatory themes relating to pharmaceuticals and medical devices as well as co-author of the “Handbuch des Arzneimittelrechts” (textbook on pharmaceutical law, in prep.). Furthermore, he holds lectures and speeches on current subjects from the pharmaceutical and medical device area. Languages: German, English and French.

 

About Lawford Davies Denoon

Lawford Davies Denoon is an exciting new law firm specialising in Life Sciences. Lawford Davies Denoon primarily advises on regulatory and intellectual property matters related to the life sciences sector.

In addition to experience of advising pharmaceutical and medical device companies, we work with a range of clients and partners in both the public and private sectors.  Our ability to meet the different requirements of our clients is reflected in the range of services we provide, which includes:

•   Negotiating, drafting and advising in relation to commercial agreements
•   Litigation
•   Training
•   Consultancy services
•   Regulatory advice

From our extensive experience of assisting clients to devise and implement strategies to protect, defend and commercialise intellectual property, to our excellent  track record in litigation and our long-standing advisory relationships, Lawford Davies Denoon provides a specialist, trusted and expert service in this dynamic and challenging field.

 

   Media Partner

 Balkans.com Business News is a prominent and recognized voice for business globally. As a Balkans business resource, we provide up-to-date daily news and weekly reviews, market research, financial reports, company news linking and database of companies who do business in Albania, Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, FYR Macedonia, Greece, Montenegro, Romania, Serbia, Slovenia and Turkey. In addition, our notable industry news section provides detailed information on business happenings for over 30 specific industries. Our readers are high-level executives, business leaders, educational institutions, investors, business owners and government institutions throughout the world.

The business-only website in English, Serbian and Greek keeps our readers up-to-date with its comprehensive coverage of the region, in-depth analysis of industries and business opportunities, interviews with business leaders, special reports and a searchable database.
http://www.balkans.com/index.php

Masterclass programme

13:00 Registration & Coffee

13:30 An overview of the new Bribery Act and particularly the corporate offence of Bribery as a result of the conduct of a single employee or agent. COmparison with other jurisdictions. The interaction with the ABPI Code of Practice and the historic Memorandum

Alexander Denoon

Alexander Denoon, Partner, Lawford Davies Denoon

14:00 The importance of the new Bribery Act in every aspect of the life cycle of products in the Life Sciences sector: R&D, collaboration agreement, clinical trials, post-marketing surveillance, consultancy agreements, educational grants and sponsorship.

Mathias Klumper

Mathias Klumper, Partner, Lützeler und Partner, Rechtsanwälte

  • Interactions with Healthcare Professionals generally
  • Specific agreements
  • Scenarios and "war stories"
  • 15:00 The importance of the new Bribery Act in every aspect of commercial transactions in the Life Sciences sector: joint ventures, distribution agreements, licences, M&A transactions.

    Erik Vollebregt

    Erik Vollebregt, Partner, Axon Lawyers

  • Consideration of every aspect of commercial relationships and M&A transactions - structuring agreements.
  • What to consider in due diligence related to commercial relationships and M&A transactions.
  • Scenarios and "war stories": learning from recent cases
  • 16:15 Coffee break

    16:35 Worked example group exercise - one from the interactions with HCPs and one from M&A transactions

    Alexander Denoon

    Alexander Denoon, Partner, Lawford Davies Denoon

    Erik Vollebregt

    Erik Vollebregt, Partner, Axon Lawyers

    Mathias Klumper

    Mathias Klumper, Partner, Lützeler und Partner, Rechtsanwälte

    17:15 End of workshop and private consultations with attendees

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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, SMI 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@smi-online.co.uk

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