Regulatory Affairs & International Market Access
Regulatory Affairs & International Market Access
Understanding Regulatory Requirements and Successfully Applying Them in Practice
The international development and authorization of medical devices, in vitro diagnostics, pharmaceuticals, and combination products require a comprehensive understanding of different regulatory frameworks.
Our training programs provide practical knowledge of regulatory classification, appropriate approval pathways, technical and regulatory documentation, and communication with competent authorities.
Key Training Topics:
- EU Medical Device Regulation (MDR) – Regulation (EU) 2017/745
- EU In Vitro Diagnostic Regulation (IVDR) – Regulation (EU) 2017/746
- FDA regulatory pathways for medical devices, including 510(k), De Novo, and PMA
- European pharmaceutical legislation, particularly Directive 2001/83/EC and Regulation (EC) No 726/2004
- Drug-device combination products and applicable FDA requirements under 21 CFR Parts 3 and 4
- Regulatory strategy and international approval planning for the EU, USA, and Rest of World markets
- Regulatory classification, gap assessments, and remediation
- Regulatory authority communication and documentation requirements
Our training content incorporates relevant guidance from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), Medical Device Coordination Group (MDCG), and International Council for Harmonisation (ICH).
Value for Your Organization: Stronger regulatory decision-making capabilities, earlier identification of approval risks, and more efficient planning of international market access activities.