EU procedures for marketing authorisation approval and post-authorisation obligations - US edition MasterClass

24-25 May, 2023

Are you planning to enter the EU market and/or expand your market in the region?

This course provides an overview of the background to and procedures available for obtaining marketing authorisation approval in the EU and post approval obligations.

24-25 May, 2023, Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

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Key learnings

Overview

Overview of the EU regulatory environment

Knowledge

Knowledge of EU authorisation procedures

Relevant Factors

Relevant factors to consider in procedures

EU Documentation

Brief discussion of EU documentation

Obligations

Post authorisation obligations

Discuss

Discuss post-Brexit changes

Trusted by over 17,000 delegates across leading companies

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Pharma Online MasterClass

Overview

Are you planning to enter the EU market and/or expand your market in the region? This course provides an overview of the background to and procedures available for obtaining marketing authorisation approval in the EU and post approval obligations.

#masterclass #glceurope #pharmaonlinetraining #globalleadingconferences #euprocedureformarketingauthorisationapproval #postauthorisationobligations

Trainer

Norah Lightowler

Consultant
Lightowler Associates

Norah M. Lightowler, LLB, BPharm, MRPharmS, FTOPRA, is the owner of Lightowler Associates, regulatory consultants to the pharmaceutical industry offering expert advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. She has wide experience in the pharmaceutical industry including research, as a regulator with the UK regulatory authority and in regulatory affairs as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory systems, including requirements, procedures and strategy.

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Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

Gain value and learn from the best instructors

Networking

Build a top-notch community and advance your career

Who should attend img RECOMMENDATION

Who should attend?

• Regulatory Affairs Managers

• Regulatory Affairs Executives

• Project Managers

• Team Leaders Clinical

• Development

• Manufacturing

• Research

• Clinical

• Medical

• Marketing

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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