DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/dz6gnm/regulatory) has announced the addition of the "Regulatory Affairs for Support Staff" conference to their offering.
This two day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support role.
You will gain an overview of EU regulatory procedures required to register products in Europe and the regulatory activities that need to be complied with to keep products on the market. Pharmacovigilance and safety reporting will be covered as well as license variations and the commercial aspects of Pharmaceutical products. The course will provide a thorough grounding in the subject of regulatory affairs and enable you to perform in your role more effectively.
Key topics to be covered:
- Learn about the Drug Development Process - from Drug Discovery to Product Approval
- Understand the Background of EU Law - Regulations, Directives etc
- Discover where you can find Information on Regulatory Affairs, Approvals, Withdrawals etc
- Assess the Impact of the EU Clinical Trials Regulation
- Gain an Understanding of the Common Technical Document
- Discuss how to Apply for a Marketing Authorisation in the EU - the Centralised, Decentralised and Mutual Recognition Procedures
- Clarify Post Authorisation Obligations - Pharmacoviglance, Variations and Renewals
- Participants will receive a course material folder containing comprehensive documentation provided by the seminar leader, which will be a valuable source of reference for the future.
- 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/dz6gnm/regulatory