Are you wondering about the feasibility of parallel consultation, what sponsors should be aware of, as well as the opportunities and pitfalls of seeking this process? Here is to clarify your doubts 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
Peter Hession, BA, MBBS, DipPharmMed, MFPM, Medical Director
As a Medical Director at VCLS, Peter’s main responsibilities include: the drafting and critical review of clinical development plans, including gap analysis; drafting and critical review of the clinical parts of briefing documents and presentations for EMA Scientific Advice, national scientific advice, and regulator/health technology assessment bodies parallel consultations.