Dublin, May 31, 2019 (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.

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 n 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

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

Speakers:

Norah Lightowler
Management Forum

Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twentieth year of successful business.

Norah has wide experience in the pharmaceutical and related neutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy.



For more information about this conference visit https://www.researchandmarkets.com/r/6uyu15

About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

CONTACT: ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Drug Discovery