|
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
|
|
Events Home Page
