Dublin, Feb. 14, 2020 (GLOBE NEWSWIRE) -- The "Regulatory Affairs for Support Staff" conference has been added to ResearchAndMarkets.com's 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 staff role.

Working in pharmaceutical regulatory affairs is a complex role, with involvement in not only the drug development stages but also post drug-approval activities and marketing.

This interactive course, designed specifically for those working in a support staff role, provides a valuable introduction to pharmaceutical regulatory affairs and key responsibilities.

Participants will gain an overview of the 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.

The programme will cover pharmacovigilance and safety reporting with sessions on licence variations, the commercial aspects of pharmaceutical products and the potential impact of Brexit. The course will provide a thorough grounding in the subject of regulatory affairs and enable support staff to perform more effectively.

Discussion sessions and the use of case studies throughout the two days will help consolidate learning.

Benefits of Attending

• Understand the background of EU law - regulations, directives, and guidelines
• Consider the potential impact of Brexit
• Gain an understanding of the Common Technical Document n Discuss how to apply for marketing authorisation in the EU - the centralised, decentralised and mutual recognition procedures
• Clarify post-authorisation obligations - pharmacovigilance, variations, and renewals
• Assess the impact of the EU Clinical Trial Regulation

Who Should Attend?

This course is designed for anyone working in regulatory affairs including administrators, assistants 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 provide support to the regulatory procedures and activities.

Agenda

Programme - Day one

European law - regulations, directives, and guidelines

• Impact of Brexit

Where can we find information on regulatory affairs?

• 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 new Clinical Trial Regulation

• What is the process of running clinical trials in Europe?

Seeking scientific advice in Europe

• What are the processes?

The CTD

• Structure and content of a CTD

The European Medicines Agency

• Impact of Brexit

Programme - Day Two

Applying for marketing authorisation in the EU with a 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 Brexit

Managing product labelling

• Company core data sheets
• Updates to the summary of product characteristics

Post-authorisation obligations: pharmacovigilance, variations, and renewals including discussion on the impact of Brexit

• What to expect

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/s5xj86

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