DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/7gmc3l/regulatory) has announced the addition of the "Regulatory Affairs for Support Staff - An Overview of the Pharmaceutical Regulatory Affairs for Support Staff" conference to their offering.
24 & 25 September 2014 - The Rembrandt Hotel, London
This two day course provides an introduction to Regulatory Affairs and the basics of drug development and has been designed specifically for those working in a support staff role.
The first day will provide an overview of the EU Regulatory procedures, an insight into applying for clinical trials applications and seeking scientific advice and how to maintain product labeling whilst complying with pharmacovigilance requirements.
You will gain an overview of the basics of the registration procedures and how to organise the registration files. The second day will focus on the procedures required to register products in Europe and the Regulatory activities that need to be complied with to keep products on the markets.
Pharmacovigilance and safety reporting will be covered as well as licence variations and the commercial aspects of pharmaceutical products. The course will provide a thorough grounding in the subject of Regulatory Affairs and will enable you to perform in your role more effectively.
TOPICS TO BE COVERED:
- Learn about the Drug Development Process - from Drug Discovery to Product Launch and Beyond
- Understand the Background of European Law - Regulations, Directives, etc.
- Discover where you can find Information on - Regulatory Affairs, Approvals, Withdrawals, etc.
- What is the Centralised Procedure
- How to Seek Scientific Advice i- Europe
- What is the Common Technical Document
- Applying for a Marketing Authorization in the EU
- Key Aspects of Drug Safety Reporting
- Pharmacovigilance and GCP Inspections
- Managing Product Labelling
- Discussio- o- Licence Variations
- Understand Parallel Imports and Generic Applications
A Certificate of Attendance for Professional Development will be given to each participant who completes the course
For more information visit http://www.researchandmarkets.com/research/7gmc3l/regulatory
