Product Life Cycle Activities

Get an understanding of the basic regulatory requirements for a pharmaceutical product in the post-approval phase

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  • 2. Dec 2019
  • 1. Dec 2020

3 days course

English

17.650,- DKK ex VAT
(app. 2.373,- EUR ex VAT)

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Module 9

Summary

This module will teach you about the regulatory possibilities and consequences of different types of life cycle activities, and enable you to develop strategies as well as plan and perform activities related to the regulatory maintenance of a product in an everyday working environment. You will learn about the regulations and legal framework related to product life cycle management, and you will gain knowledge of and insight into regulatory requirements and opportunities in life cycle management

Our focus will be on the current EU regulatory legislation and guidelines, but you will also get a brief overview of life cycle activities related to interactions with stakeholders from the safety, marketing, legal and communication fields. Throughout the course, we will discuss dilemmas and decisions for regulatory professionals during the life cycle of a product.
  

Keywords

The EU Variation System
Labeling Requirements
Renewals
Change Control Systems
Maintenance of the EU Product Information
New Indications and Extensions
Pediatric Regulation
Implementation of Pharmacovigilance Legislation
Implementation of Risk Management Plans and Periodic Safety Update Reports (PSURs)
Crisis Management
Referrals
Intellectual Properties

What you will learn

  1. The basic regulatory requirements for pharmaceutical products in the post-approval phase and regulations concerning pediatrics, risk management plans, referrals and generics
  2. How and when to apply for variations for CMC changes, labeling updates, SPC updates and renewals
  3. How to analyze and evaluate regulatory concerns and risks in life cycle management using relevant regulations, guidelines and best practices in order to maintain regulatory compliance
  4. How to advise and decide on the optimal regulatory strategies for life cycle management projects

What your company will get

  1. A regulatory professional who understands the basic regulatory requirements for a pharmaceutical product in the post-approval phase and the regulations concerning pediatrics, risk management plans, referrals and generics
  2. A regulatory professional who knows how and when to apply for variations
  3. A regulatory affairs professional who is able to analyze and evaluate regulatory concerns and risks in life cycle management and knows how to be regulatory compliant
  4. A regulatory affairs professional who is able to advise and decide on the optimal regulatory strategies for life cycle management projects
Available start dates
All course dates: 2. Dec 2019, 3. Dec 2019, 4. Dec 2019
All course dates: 1. Dec 2020, 2. Dec 2020, 3. Dec 2020
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Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick and cannot attend the course, you may hand over the seat to a colleague, who will then have to register for the course on our website prior to course start. If the registration is closed, please send us full name, email, phone and title of your colleague to bfl@atriumcph.com. Read our cancellation policy.

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This course is a part of this programme

Regulatory Affairs Diploma

Theoretical and practical aspects ... Read more

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

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