RPN Academy
LEARN FROM EXPERTS
RPN delivers high quality customized training courses to personnel directly on site or via web, as preferred.
RPN can cover all the major areas of interest for the Pharmaceutical and MedTech industry. The training can be organized as a single session or incorporated in more complex training plans that involve multiple experts covering different topics.
We can support our client companies in the design and execution of personalized training plans and help them comply with their training standards and with current regulatory requirements.
Common topics addressed in our training sessions:
| Promotion | Advertising and promotional requirements including EFPIA code |
| Promotion and Pharmacovigilance requirements for Sales Reps | |
| Drug development | Roadmap to Europe for non-EU companies |
| Early dialog procedures (Scientific Advice, ODD, PIP) | |
| Quality | Quality compliance (GMP, ISO 9001, ISO 13485, etc.) |
| Pharmacovigilance | Pharmacovigilance and Medical information |
| Value & access | Launch readiness plan |
| Health economics | |
| Early access programs | |
| Joint Clinical Assessment (JCA) | |
| Regulatory Affairs | Registration procedures |
| Maintenance of marketing authorizations | |
| Development of CTD | |
| Module 3 and 2.3 of the CTD | |
| Regulatory publishing for EU (eCTD) | |
| MedTech | Medical Device Regulation |