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.
This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation. The impact of Brexit on the regulatory requirements for companies operating in the important pharmaceutical markets in Great Britain and Northern Ireland will be discussed.
The programme will cover the legal basis of regulation, development strategies and the importance of pre-submission activities as well as an overview of the format for presentation of data, the registration procedures and post-authorisation obligations and strategic considerations. The impact of post-Brexit changes on obtaining and maintaining marketing authorisations in the UK will be discussed.
Case studies and discussion sessions throughout the two days will explore options and strategies for key regulatory activities and will provide an opportunity to share experiences with our expert trainer and other delegates.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits of attending
- Understand the legal basis of the EU regulatory environment
- Review procedures for applying for a marketing authorisation in the EU/EEA and in the UK
- Discuss the impact of Brexit and consequent changes
- Discuss development strategy and pre-submission activities
- Discuss post-authorisation obligations and strategic considerations