The European Union is the second worldwide market for health products. The European Medicines Agency (EMA) is responsible for the scientific evaluation of certain medicines for use in the European Union, whereas other health products are regulated by different bodies (e.g. national Competent Authorities, Notified Bodies or the European Food Safety Authority – EFSA). The regulatory landscape is evolving towards a more harmonized, pan-European setting, although certain prerogatives still remain with national regulators – approval to conduct clinical studies for instance. As regards payers, the rise of Health Technology Assessment poses a challenge to the industry for reaching a consensus across a myriad of national agencies of often different viewpoints (e.g. on choice of comparator for pivotal studies, clinical studies endpoints or health economics assessment methods).
Frequent interactions with regulators and payers throughout health product development are necessary to efficiently integrate the abundant mix of national and European requirements, opinions, legal texts and regulatory guidelines.
Located in France (Paris and Rennes) and the United Kingdom (Southeast of London), the VCLS European team serves European and international clients in communicating with the EMA, national regulatory agencies, central or local ethics committees, notified bodies and Health Technology Assessment bodies.
- Preparation for strategic meetings with regulators (Innovation Task Force, Committee for Advanced therapies, scientific advice, qualification of novel methodologies, MAA pre-submission meeting and oral explanation)
- EMA and national agencies meetings
- Orphan Drug Designations (ODD)
- Pediatric Investigation Plans (PIP)
- Clinical Trial Applications (CTA)
- Marketing Authorization Applications (MAA)
- CE-marking technical file
- Accelerated Assessment Procedure (AAP)
- Safety reporting
- National, joint advice from Payers (SEED early dialogue), parallel advice from regulators and payers
- EU Legal Representative for clinical studies
- Applicant for Clinical Trial Applications
- EU Sponsor for Orphan Drug Designations
- EU representative for Small- and Medium-sized Enterprises (SME status)
- Qualified Person for Pharmacovigilance (QPPV)
- EudraVigilance responsible person