When: 18 March 2019
Where: Celgene, 86 Morris Avenue, Summit, NJ 07901, USA
Time: 08:30 - 16:00
Course overview
This course provides an opportunity that on-the-job learning doesn't: network and learn from experts, including 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, labeling, 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
- Build a network to support the rest of your career
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
Programme:
8:30 - 9:00 Registration
9:00 - 16:00 Course
Breaks at various times during the course programme.
Presenter
Carlos Langezaal - Senior Director, Regulatory Affairs, Celgene
Suitable for
This course is designed for those who are new to, or need a refresher of European Regulatory Affairs.
Pricing
Course fees:
| Type |
Fee |
| Standard |
£399 |
| (approx equivalent cost US$500) |
| |
|
|
- The registration fee does not include accommodation
- Refreshments and lunch are included in the registration fee
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Next steps