Course overview
This interactive course provides an overview of pharmaceutical regulatory affairs and its key responsibilities and would be of value for those new to the function or in support or interactive roles.
Navigating the complexities of regulatory processes, particularly in the context of evolving legislation, can be challenging.
Participants will gain knowledge of current and proposed EU legislation revision and of regulatory procedures available to register products in the EU and the regulatory activities required to maintain products on the market.
The UK is no longer a member of the EU but interactions and collaboration with the EU and other regulatory agencies for obtaining and maintaining marketing authorisations in the UK will be discussed.
Discussion sessions and practical case studies will help to consolidate learning, providing attendees with the skills and knowledge to be effective in their roles within the pharmaceutical industry.
CPD Hours: 12
Course Content
- Day 1
- Current EU legislation
- Drug Development
- Clinical trials in Europe
- Seeking scientific advice in Europe
- Marketing Authorisations
- Overview of the structure and content of a CTD
- Procedures for Marketing Authorisation in the EU
- EU centralised procedures
- Day 2
- Non-centralised procedures for marketing authorisation in the EU and in the UK
- Abridged applications and generics
- Product life cycle; post approval
- Parallel trade
- Post-authorisation obligations
- Pharmacovigilance
- Licence variations
- Extensions
- Renewals
- Sunset clause
- Managing and supporting a regulatory affairs department
Speakers
Norah Lightowler
Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twenty fourth year of successful business. She has wide experience in the pharmaceutical and related nutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy.
