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Regulatory Affairs for Support Staff (London, United Kingdom - March 19-20, 2020) - ResearchAndMarkets.com

February 4, 2020 GMT

DUBLIN--(BUSINESS WIRE)--Feb 4, 2020--

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:

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

Where can we find information on regulatory affairs?

The drug development process

Case Study 1

The EU Clinical Trials Directive and new Clinical Trial Regulation

Seeking scientific advice in Europe

The CTD

The European Medicines Agency

Programme - Day two

Applying for marketing authorisation in the EU with a discussion on the impact of Brexit

Case Study 2

Generic applications

Parallel trade

Managing product labelling

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

Licence variations

Case Study 3

Renewals

Managing and supporting a regulatory affairs department

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/fez8n0

View source version on businesswire.com:https://www.businesswire.com/news/home/20200204005483/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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KEYWORD:

INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL

SOURCE: Research and Markets

Copyright Business Wire 2020.

PUB: 02/04/2020 06:09 AM/DISC: 02/04/2020 06:09 AM

http://www.businesswire.com/news/home/20200204005483/en