DUBLIN--(BUSINESS WIRE)--The "Regulatory Affairs for Support Staff" conference has been added to ResearchAndMarkets.com's offering.
This 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.
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/research/xgw3z9/2day_course?w=4
