DUBLIN, Apr. 01, 2015 /PRNewswire/ --Research and Markets
(http://www.researchandmarkets.com/research/sc5vm6/eu_pharmaceutical) has announced the addition of the "EU Pharmaceutical Regulations" conference to their offering.
This course will provide you with an up-to date overview of the European pharmaceutical regulatory environment, procedures and obligations.
You will learn about the legal basis of regulation, how the registration procedures work, the format for presentation of data and the importance of pre-submission actions and post authorisation obligations. There will be discussion on US differences.
It will be of particular value as an introductory or refresher course for those involved in regulatory affairs or fo those who interact with regulatory personnel to understand action time-lines and requests for information.
Key Topics To Be Covered At The EU Pharmaceutical Regulations Meeting
- Understand the legal basis of the EU Regulatory environment, including key regulations, directives and guidelines
- What are the key development and Pre-Submission Activities
- Understand the Procedures for applying for a Marketing Authorisation in the EU.
- Discuss Post Authorisation obligations, such as Pharmacovigilance, Variations and Renewals
- Compare FDA v EU procedures.
- Norah Lightowler, Partner Lightowler Associates
For more information visit http://www.researchandmarkets.com/research/sc5vm6/eu_pharmaceutical
Media Contact: Laura Wood , +353-1-481-1716, firstname.lastname@example.org
SOURCE Research and Markets