Successful EU-US Clinical Drug Development: How to address both markets without duplicating work? June 12th, 2014 - 14:00-17:30 EPFL - Innovation Park (Parc Scientifique) Building D, Room "Pluton" (Ground Floor) Lausanne, Vaud FREE OF CHARGE "The regulatory environment is one of the most important external factors affecting a company's organization, processes, and technological strategy" With tangible differences in requirements from a market to another, global drug development is often perceived as a daunting challenge. Voisin Consulting Life Sciences invites you to an interactive discussion on how to bridge FDA and EMA requirements, from the design of global clinical development strategies to the adaptation of implementation in each local market. International regulatory experts will share their experience of dealing with conflicting requests from regulators, to optimize the value of clinical-stage drugs. Successful EU-US Clinical Drug Development: How to address both markets without dupkicating work? Switzerland, and especially the Geneva lake area, remains the cradle of innovation for the healthcare industry, offering amazing opportunities to biotech and pharmaceutical companies to successfully develop and launch drugs. However, within a constantly evolving regulatory environment, designing a global clinical development strategy is becoming increasingly challenging! Three main factors are proven to address disparate regulatory requirements across the Atlantic, and hence to ensure successful clinical development: • • • Conducting global clinical development programs, from Phase 1 to the market, bridging discrepancies across markets - including payers considerations; Continuously interacting with health authorities throughout clinical testing; Addressing country-specific requirements, and benefiting from local market incentives. This interactive discussion will be based on real-life experience, gained both in the industry and as advisors. After a coffee break, the discussion will go on about the local execution of clinical development strategies in each market, accounting for local regulatory frameworks and opportunities to accelerate the setup of clinical studies in Europe and the US. Participants will be invited to share individual experiences, and directly interact with regulatory experts with a successful industry track record. The workshop will be followed by a networking Aperitif. June 12th, 2014 - 14:00-17:30 EPFL Innovation Park Building D, Room "Pluton" (Ground Floor) Lausanne, Vaud 14:00 Global clinical development strategy: obtain feedback from regulators 15:30 Coffee Break 16:00 Adapt clinical study setup in each market 17:00 Networking Aperitif For any questions, please call 021 693 92 71 Mark A. De Rosch, PhD. Frederic Pailloux, Pharm.D. Vice President, Head of US Operations & Regulatory Drugs/Biologics Voisin Consulting Life Sciences, Cambridge, MA, USA Senior Director, Head of Swiss Operations & Deputy Qualified Person Voisin Consulting Life Sciences, Lausanne, Switzerland Mark is responsible for the management of projects involving the design and implementation of global regulatory strategies for the development, registration, and maintenance of drug and Medtech products. Mark has more than 20 years' experience in the industry, especially in preparing teams for and leading discussions with regulatory agencies, including FDA, EMA and EU National Agencies. Frederic leads projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of small molecules and biologics. Over 15+ years of experience in the pharmaceutical and biotech industry, Frederic gained an in-depth understanding of the EU regulatory landscape, and is versed into liaising with the EMA and National Competent Authorities, including Swissmedic. Delphine Decker, M.Sc. Director, Head of Clinical Trials Management Voisin Consulting Life Sciences, Paris, France Delphine leads activities related to Clinical Trials Applications, and became an expert in the recent Voluntary Harmonized Procedure (VHP) as well as in navigating country-specific requirements. She has extensive experience in designing and implementing regulatory strategies for the clinical development and registration of drugs and innovative medicinal products. Contact Voisin Consulting Life Sciences www.voisinconsulting.com EPFL Innovation Park, Lausanne, 1015, Switzerland +41 (0)21 693 92 71 [email protected] Follow us on LinkedIn