EU Pharmaceutical Regulations & Strategy
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 overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.
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 for obtaining marketing authorisations and post-authorisation obligations and strategic considerations. The impact of post-Brexit changes for obtaining and maintaining marketing authorisations in the UK will be considered.
There will be a number of case study sessions throughout the two days to explore options and strategies for these key regulatory activities, which will provide an opportunity for discussion and the sharing of experiences with our expert trainer and other delegates.
Upcoming start dates
Suitability - Who should attend?
Benefits of attending
- Understand the legal basis of the EU regulatory environment
- 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
- Explore the impact of post-Brexit changes
- Discuss the proposed EU pharmaceutical legislation changes
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Reviews by course attendees
Average rating 4.2
Content et presentation very clear
Good overview of the regulatory topics concerning the product life-cycle. Availability to clarify and discuss doubts; challenge of the participants mind set;
Overall it was a good webinar that covered a wide range of topics essential for professionals working in or close to regulatory affairs