When: 14-15 June 2021
Where: Online
Day 1 start time: 16:00 (BST) | 11:00 (EST)| 08:00 (PST)
Day 2 end time: 20:00 (BST) | 15:00 (EST) | 12:00 (PST)
Course overview
This course provides an opportunity to learn from experts and your fellow delegates. By attending this course, you will:
- Get a clear understanding of the roles played by regulatory affairs professionals obtaining and maintaining marketing authorisation for medicines
- Learn the key steps involved in developing new pharmaceuticals
- Get insights about the strategies needed to be applied by regulatory affairs professionals to obtain best results for their organisations and stakeholders
- Gain an overview of EU legislative framework
- Understand the essentials of clinical trials, EU marketing authorisation procedures, labelling, advertising, post-authorisation activities, including variations, and EU specific challenges.
Benefits to delegates
- Get a complete grounding in regulatory affairs in just one day
- Be taught by regulatory affairs experts with extensive practical examples
- Understand the regulatory affairs sector and find out for yourself how you can maximise your performance, either as a regulatory professional or working alongside regulatory colleagues
CPD: This course provides 7 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
Download a copy of the course programme here.
Presenter
Carlos Langezaal
Senior Director, Regulatory Affairs, Bristol-Myers Squibb
Suitable for
This course is designed for those who are in based the United States and are new to, or need a refresher of European Regulatory Affairs.
Pricing
- Members: £349 + *VAT
- Non-members: £399 + *VAT
*VAT, if applicable, is charged at VAT of 20%
Terms and conditions
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.