Dublin, May 30, 2019 (GLOBE NEWSWIRE) -- The "Regulatory Affairs for Support Staff" conference has been added to ResearchAndMarkets.com's offering.
An overview of pharmaceutical regulatory affairs for support staff
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 staff 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.
Course overview
Key Topics to be be covered:
- Understand the Background of EU Law - Regulations, Directives and guidelines
- 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
Who Should Attend:
This course is specifically designed for anyone working in Regulatory Affairs, including personal assistants, secretaries, administrators and any member of support staff wishing to gain a greater understanding of Regulatory Affairs in the Pharmaceutical Industry. It is also suitable for those who interface with the Regulatory Affairs function and who provide support to the Regulatory procedures and activities.
Agenda:
Programme - Day one
European Law - Regulations, Directives
- Impact of Brexit
- Where can we find the information on regulatory affairs, approvals, withdrawal?*
- The Internet/publications
- Approvals and withdrawals
The drug development process
- Drug discovery
- Pharmaceutical R&D
- Non-clinical tests
- Clinical studies - Phase I to IV
- Registration
CASE STUDY 1
- The EU Clinical Trials Directive and Regulation*
- What is the process for running clinical trials in Europe?
Seeking scientific advice in Europe
- What are the processes?
The Common Technical Document
- Structure and content of a CTD
The European Medicines Agency
- Impact of Brexit
Impact of Brexit
Programme - Day two
Applying for a Marketing Authorisation in the EU with discussion on the impact of Brexit
- The EU Centralised Procedure
- Decentralised Procedure
- Mutual Recognition Procedure
- National procedures
CASE STUDY 2
Generic applications
- Requirements
Parallel trade
- How the process works
- Impact of Bexit
Managing product labelling
- Company core data sheets
- Updates to Summary of Product Characteristics
Post Authorisation Obligations; Pharmacovigilance, variations and renewals including discussion on the impact of Brexit
Pharmacovigilance and GCP inspections
Licence variations
- Type I and Type II variations
- Procedures and timelines
CASE STUDY 3 Renewals
Managing and supporting a regulatory affairs department
- Things to consider
- Maintaining oversight
For more information about this conference visit https://www.researchandmarkets.com/r/8d4by4
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.