Please join us for an inside look at how the latest legal and regulatory developments in EU law will affect companies operating in the life sciences space. We will bring together senior members of the European Commission and regulatory and business community to address the potential impact of new pharmaceutical and medical devices legislation and regulation. Sessions will cover medicinal products, including clinical trials, pharmacovigilance and orphan medicinal products, and medical and in vitro diagnostic devices, as well as competition law issues affecting the pharmaceutical sector. Our panelists/speakers will also discuss the foreseeable impact of Brexit on the life sciences industry.
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- Salvatore d’Acunto, Head of Unit, DG Internal Market, European Commission
- Andreas Balsiger Betts, Head of Legal Affairs, Swissmedic
- Lee Betteridge, Director, Head of UK Pharmaceutical and Life Sciences Forensic Services, PricewaterhouseCoopers
- Ray Cresswell, Regulatory and Therapeutic Area Lead Legal Counsel, Gilead
- Paul Csiszár, Director, DG COMP, European Commission
- Rhianon Ebsworth, Senior Corporate Counsel, Novo Nordisk
- Zahra Hanaizi, Scientific Officer, European Medicines Agency
- Max Müller, Chief Strategy Officer, Doc Morris
- Jo Pisani, Partner, PricewaterhouseCoopers
- Giorgio Rizzello, Legal Director EMEA, Johnson & Johnson
- Andrzej Rys, Director, DG SANTE, European Commission
- Attila Sipos, Member of the Legal Service, European Commission
- Jerry Temko, Former Senior Vice President and General Counsel, Astellas Pharma Europe
PROGRAM TOPICS INCLUDE
The EU legislative and regulatory framework for pharmacovigilance and clinical trials has been undergoing visible changes in the past 10 years, notably after the entry into force of the EU pharmacovigilance requirements in 2012 and the adoption of the clinical trials regime in 2014, which is currently being implemented. Throughout the sessions, our speakers will discuss the latest developments on those fronts, as well as the recent EMA public consultation on orphan medicinal products, the EU PRIME scheme, among other topics.
Medical Devices and IVDs
In June 2016, the European Parliament and the European Council endorsed two new regulations on medical devices and in vitro diagnostic devices. The new regulations represent a major overhaul of existing rules in the EU. Hear how these new rules will become more stringent, with stronger requirements and greater surveillance, and how life sciences companies can comply with the regulatory changes once they are in force. Our speakers will focus on the changing landscape of medical device legislation and on recent enforcement trends of the current regulatory framework.
The Brexit Effect
The UK has voted to leave the EU after 43 years of membership. This historic decision is likely to have a profound impact on many different areas of law and regulation, and it will need to be carefully examined and monitored. The life sciences industry is likely to witness changes throughout the life cycle of its products, from early development to post-market stages. Join us for an interactive panel discussion with regulators and industry representatives as we assess the impact of Brexit on life sciences in the UK.
The event is open to in-house counsel, regulators and regulatory personnel at pharmaceutical and medical devices companies. There is no registration fee to attend this event. Due to space limitations for this event, registrations will be reviewed and confirmed by email.
For more information, please contact Cristina Menendez Ruiz at +32 2 504 64 53 or firstname.lastname@example.org.