Course overview
In the highly regulated field of pharmaceuticals, staying abreast of regulatory affairs is invaluable for ensuring compliance, maintaining market authorisations, and effectively managing drug development and post-approval obligations. Navigating the complexities of regulatory processes, particularly in the context of evolving legislation, can be challenging.
Creating and coordinating an effective regulatory strategy is an important part of the work of a regulatory affairs department and can save valuable time and money. It is therefore necessary to be aware of potential changes and new procedures and methodologies which may impact on planning and strategy.
This interactive course will provide an overview of the current European pharmaceutical regulatory environment, procedures and obligations. Political agreement on changes to EU pharmaceutical legislation has been reached. Implementation and transition timelines will be discussed.
The programme will cover the legal basis of EU regulation, development strategies and the importance of pre-submission activities, a brief overview of the format for presentation of data, the registration procedures for obtaining marketing authorisations and post-authorisation obligations and strategic considerations. The increasing use of AI in product development, manufacturing and post-authorisation activities will be considered in the relevant sections.
The UK is no longer part of the EU but it is a major pharmaceuticals market and knowledge of interactions and collaboration with the EU and other regulatory agencies are important for obtaining and maintaining marketing authorisations in the UK.
Case study sessions will explore options and strategies for key regulatory activities and provide an opportunity for discussion and the sharing of experiences with our expert trainer and other delegates.
CPD Hours: 12
Course Content
- Day 1
- EU regulatory environment: legal basis
- Information sources
- Case study one
- Development and strategy with the use of AI
- Development process
- EU Clinical Trials Regulation
- Types and categories of marketing authorisations
- Adaptive marketing authorisation procedures
- The Common Technical Document (CTD)
- Procedures for obtaining a marketing authorisation in the EU and EMA (current procedures and proposed changes)
- Other EU centralised procedures
- Day 2
- Other procedures for obtaining a marketing authorisation in the EU
- Managing product labelling
- Case study two
- Abridged applications and Generics
- Product life cycle; post approval
- Patents and SPCs
- Parallel trade
- Post-authorisation obligations; pharmacovigilance, variations and renewals
- Pharmacovigilance
- Licence variations
- Extensions
- Case study three
- Renewals
- Sunset clause
- Phase IV clinical studies
- Classification change
- Generic development
- Strategic considerations (summary)
- Criteria for successful products
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.
