Two Day UK Course: Pharmaceutical Regulatory Affairs for Support Staff – London, United Kingdom – September 23-24, 2019 – ResearchAndMarkets.com

BusinessWire

5 years ago

DUBLIN–(BUSINESS WIRE)–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.

By attending this course 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
licence variations and the commercial aspects of pharmaceutical
products. The potential impact of Brexit will also be discussed. The
course will provide a thorough grounding in the subject of regulatory
affairs and enable you to perform in your role more effectively.

Benefits of attending:

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