Brexit’s Promises and Problems: Mapping Out New Strategy for Life Sciences Industry
As United Kingdom decided to step out of the European Union’s (EU) umbrella – with its 52% Brexit Vote – last June 23, 2016, the consequences and after-effects are likely to be profound but are uncertain. Many sectors are still wondering the next steps to take from this significant change. The UK life sciences sector, in particular, was against leaving the EU and feared it’s impact before the vote.
With uncertainty still clouding the process and impact of the UK’s decision, the Life Sciences Industry is looking at how best to mitigate the worst and embrace the best of this change. The next steps, however, will be tough to devise.
To find out what could be the best approaches for the Life Sciences sector, The Knowledge Group has assembled a panel of key thought leaders and professionals in a two-hour LIVE Webcast. Speakers will discuss the significant issues and provide their insights on how to strengthen strategies to try to safe guard the interest of the life sciences industry. They will also provide a comprehensive outlook of the impacts and implications of Brexit to research; clinical trials; regulation and quality assurance of medicinal products; pharmacovigilance; Health Technology Assessment and to patent rights for products.
Key topics include:
- Impacts and Implications to the Life Sciences Sectors
- Identifying Risks and Opportunities
- The future of key agencies and networks: EMA, NICE and others
- What's Next for the Life Science sector
Leela Barham, Health Economist
Leela Barham Economic Consulting Ltd
Key focus: How is the UK performing against European peers on life science metrics?
- Useful indicators
- Balance of trade
- Science graduates
- R&D spend
- Life science citations
- MHRA lead role
- UK clinical trials
Anthony Barron, Senior Associate
CRA International, Inc.
- Impacts and Implications of Brexit on the Life Sciences sector (research, product development and approval regulation, manufacturing and trade, market access) – main findings of the CRA report for EFPIA
- The future of health agencies (NICE, EMA etc.)
- Identifying risks and opportunities for both Britain and the EU
Julian Hitchcock, Counsel
Denoon Legal Ltd
- Distinguishing EU & UK life science law
- Most UK life science law is EU law, with certain important exceptions.
- EU life science law that is effectively UK law
- The UK (e.g. through the MHRA and DEFRA), has had a greater impact on legislation than any other Member State, with a dedicated Life Science Minister. Examples: data protection, IVDs, Horizon 2020….
- Opportunities from Brexit
- False opportunities - what we can already do.
- International re-allignment
- EMA staff
- Access to medicines
- GMO legislation/synthetic biology
- Rationalising ATMPs
- Biomedical data laws
- Lower standards.
- Non-tariff barriers
- Skill mobility
- Disintegration of research networks
- Regulatory burden - more regulations and regulators
- Supply chain disruptions
- Lower standards
Who Should Attend:
- Bio/Pharma and Related Attorneys
- Bio/Pharma Industries Executives
- Drug Regulation Officers
- Intellectual Property Legal Counsel
- Trade Regulation Officers
- Risk and Compliance Officers
- Medicinal Drug Manufacturers, Importers and Exporters
- Healthcare Industry Executives
- Bio/Pharma Industries
- Related Professionals/Organizations
Leela Barham is a Health Economist by training with an MSc Health Economics from the University of York and BSc Economics from the University of Nottingham. Leela has over a decade of experience in consulting, working with clients from across the world.
Leela focuses on policy and health economic issues from the pharmaceutical pricing to Health Technology Assessment and more. Leela has worked with patient organisations, the NHS, a health insurer, think tanks, the pharmaceutical industry and the medical device industry.
Leela has also worked for the Royal College of Nursing and NERA Economic Consulting and been a member of the Department of Health's External Advisory Group on Payment by Results and the HFMAs Costing Special Interest Group.
Leela's work has been published in a number of journals and she also regularly contributes to pharmaceutical industry magazines. She has also been a peer reviewer for journals including the European Journal of Health Economics and The Patient.
Leela Barham is a Health Economist by training with an MSc Health Economics from the University of York and BSc …
Mr. Anthony Barron is a senior associate in the Life Sciences Practice of Charles River Associates. He is a health economist with more than nine years of experience focused on European and global healthcare policies. Anthony has a strong understanding of health financing and pharmaceutical market access issues and has conducted a number of research projects on industrial policy in the pharmaceutical sector in Europe. This includes a report commissioned by EFPIA, on the impact of Brexit on the life sciences industry where he examined the positive and negative impact that a change in the UK relationship with the EU might have upon activities along the industry’s value chain.
Mr. Anthony Barron is a senior associate in the Life Sciences Practice of Charles River Associates. He is a health …
Julian Hitchcock is Counsel at the boutique life science practice, Denoon Legal (part of the Alliance of European Life Science Law Firms), based in London. He specialises in the law and regulation of emerging life science technologies, including regenerative and reproductive technologies, genetic and mitochondrial manipulation and synthetic biology. He provides policy, regulatory and intellectual property advice to commercial, clinical, academic, charitable, regulatory and governmental institutions. Julian is a former director of the East of England Stem Cell Network, associate of the PHG Foundation and member of the UK government's Emerging Science and Bioethics Advisory Committee. He is currently a member of the governance subgroup of the UK’s Synthetic Biology Leadership Council, a member of the Nuffield Council on Bioethics’ genome editing working party, a trustee of the UK Science Media Centre and an associate of the Innogen Institute.
Julian Hitchcock is Counsel at the boutique life science practice, Denoon Legal (part of the Alliance of European Life Science …
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Leela Barham Economic Consulting Ltd
About Leela Barham Economic Consulting Ltd
About CRA International, Inc.
Charles River Associates’ global Life Sciences practice offers diverse skills, relevant insights and extensive experience in Life Sciences policy, business strategy, finance and economics consulting. CRA focuses on delivering high quality, robust analysis but in a compelling fashion that is accessible to the target audience. CRA’s policy team provides analysis and insights into issues affecting the life sciences industry including international and national trade associations (through EFPIA, PhRMA, and IFPMA) and individual companies. CRA also commonly works for the European Commission and national governments and has a reputation for independence and rigour.
About Denoon Legal Ltd
Denoon Legal is a specialist life science law firm based in London. In addition to a broad experience of advising pharmaceutical and medical technology companies, it has particular expertise in the regulation of regenerative medicine, stem cells and other advanced therapies and embryo research. Denoon Legal is generally involved in these fast-changing areas before the law is on the statute book, whether in Brussels or in London.