European Medicines Agency (EMA) and EU member state national agencies offer Scientific Advice (SA) to medicine developers at any stage of the development process. This advice can be extremely helpful to sponsors in designing trials and maximizing the chance of success at Marketing Authorization Application (MAA). When it comes to reimbursement, national Health Technology Assessment (HTA) bodies inform reimbursement and coverage decisions, in which case HTAs include clinical benefit assessment and economic evaluation. A number of Health Technology Assessment (HTA) bodies propose HTA advice. However, divergences exist between Regulators and HTA bodies, as well as between different HTA bodies. The parallel consultation offered by EUnetHTA and the European Medicines Agency (EMA) since July 2017 is the unique opportunity to achieve a consensus between HTA bodies and EMA. This process aims to allow medicine developers to obtain simultaneous feedback from regulators and HTA bodies on their development plans to maximize their chance of marketing authorisation and reimbursement.
In this webinar we will discuss with case studies how easy and feasible is the parallel consultation in practice, what should the sponsors be aware of, as well as the opportunities and pitfalls of seeking this process.
Key learning objectives:
- Understand the benefits of EMA scientific advice, HTA advice and parallel consultation
- Know the alternative options when parallel consultation isn’t applicable or the best choice
Gabrielle Nayroles, MSc, Director, Market Access
As a Market Access Director at Voisin Consulting Life Sciences (VCLS), Gabrielle works in close collaboration with life science companies and her VCLS colleagues to provide market access strategic insight to ensure that portfolio strategy is led by optimum ROI/risk ratio and that and the technology development plan address payers’ requirements.
Delphine Kazancigil, Pharm.D, M.Sc, Director, Regulatory Science, Drugs & Biologics
Delphine Kazancigil is Director in VCLS’s office in Paris. She is an experienced regulatory science professional who has an in-depth knowledge of the European (EU) legislation and regulatory requirements.Delphine assists clients with her scientific, technical and regulatory expertise in the design of products development plans and associated regulatory and registration strategies. In particular, she has significant experience in writing pediatric investigational plans (PIP), including recommendations on the design of the PIP and in writing orphan drug designation (ODD) applications in the EU
Florence Bine-Scheck, MD, Senior Medical Director
As Senior Medical Director with VCLS, Florence is Head of the Non Clinical and Clinical Development group. She provides advice on medical and clinical aspects of projects involving the design of clinical development plans, clinical trial protocols, Scientific Advice Procedures, regulatory document writing, Risk Management Plans and Paediatric Investigation Plans.