Course overview

Working in pharmaceutical regulatory affairs is a challenging role, with involvement in the drug development stages, the marketing authorisation submission process and post-approval obligations and marketing.

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

Participants will gain an overview of current and proposed changes to EU legislation and regulatory procedures required to register products in the EU and the regulatory activities that must be complied with to maintain products on the market. The impact of Brexit on the regulatory requirements for companies operating in the important pharmaceutical market in the UK will be discussed.

The programme also covers pharmacovigilance and safety reporting with sessions on licence variations and renewals. The course will provide understanding of the role 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
Gain an understanding of the Common Technical Document
Discuss how to apply for a marketing authorisation in the EU via the centralised, decentralised and mutual recognition procedures
Clarify post-authorisation obligations – pharmacovigilance, variations and renewals
Discuss the proposed EU legislation changes
Contribute to your Continuing Professional Development (CPD)

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Who should attend?

This course is designed for personnel working in regulatory affairs including administrators, assistants and support staff wishing to gain an understanding of regulatory affairs in the pharmaceutical industry.

It will also be of value to those who interface with the regulatory affairs function or support regulatory procedures and activities.

Enrol or reserve

The Regulatory Affairs for Support Staff course will cover:

Day 1
Day 2

European law – regulations, directives and guidelines

Different legal force

Where can we find information on regulatory requirements?

The internet
Other sources

The drug development process

Drug discovery
Pharmaceutical R&D
Non-clinical tests
Clinical studies – Phase I to IV

Clinical Trials in Europe

The EU clinical Trials Regulation
Clinical trials in the UK

Seeking scientific advice in Europe

Outline of procedures

Types of and categories for marketing authorisation of applications for approval

The CTD

Overview of the structure and content of a CTD

The European Medicines Agency

Functions and responsibility

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

With discussion on the impact of Brexit

The EU centralised procedures

EU centralised procedure for marketing authorisation
Referral and arbitration

Non-centralised procedures for marketing authorisation in the EU and in the UK

Co-ordination group
Decentralised procedure
Mutual recognition procedure
National procedures

Abridged Applications and Generics

Types and requirements

Product Life Cycle; Post approval

Parallel trade

How the process works

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

Pharmacovigilance

Requirements and criteria

Licence variations

Types and timelines

Extensions

Renewals

Sunset clause

Managing and supporting a regulatory affairs department

Things to consider
Maintaining oversight

Enrol or reserve

Norah Lightowler
Lightowler Associates

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 twenty fourth year of successful business. She has wide experience in the pharmaceutical and related nutraceutical, 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.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

24-25 September 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 13891

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 20 Aug

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.