In the highly regulated field of pharmaceuticals, staying abreast of regulatory affairs is crucial 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. This is where a comprehensive understanding of pharmaceutical regulatory affairs becomes indispensable.
Creating and coordinating an effective regulatory strategy is an essential part of the work of a regulatory affairs department and can save valuable time and money. It is therefore important to be aware of potential changes which may impact on strategy.
This interactive course will provide an overview of the current European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation. The proposed EU pharmaceuticals legislation changes will be discussed in the relevant sections.
The programme will cover the legal basis of regulation, development strategies and the importance of pre-submission activities as well 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 UK is no longer part of the EU but 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.
Benefits of attending
- Understand the legal basis of the current EU regulatory environment
- Outline the background to and the proposed EU pharmaceutical legislation changes
- Discuss development strategy and pre-submission activities
- Review procedures for applying for a marketing authorisation in the EU/EEA and in the UK
- Discuss post-authorisation strategic considerations and obligations
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
