Product Life Cycle Activities, module 9

Get an understanding of the basic regulatory requirements for a pharmaceutical product in the post-approval phase
8 Mar 2023

3 days course

English

18,450 DKK ex VAT
(app. 2,481 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Module 9

Summary

This course teaches you about the regulatory possibilities and consequences of different types of life cycle activities. It also enables 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 is 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 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

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Course leader(s) & Lecturer(s)

  • Dorte Bjørn-Larsen
    Course leader
    Senior Regulatory Affairs Manager
    Novo Nordisk A/S
  • Christina Rindshøj
    Course leader
    Senior Director
    Ozack ApS
  • Peter Bachmann
    Lecturer
    Head International Liaison Office and Conferences, Executive Department European Union and International Affairs
    German Federal Institute for Drugs and Medical Devices (BfArM)
  • Anna Silke Hammerbacher
    Lecturer
    Director Regulatory Strategy
    Atrium
  • Ingrid Prieschl
    Lecturer
    Regulatory Consultant
    Zwiers Regulatory Consultancy BV
  • Lilia Nicolaeva Lisdorf
    Lecturer
    Project Lead, Global Regulatory Affairs
    FERRING PHARMACEUTICALS A/S
  • Anne-Sofie Thøger Andersen
    Lecturer
    Regulatory Specialist, Product Lead
    Novo Nordisk A/S
  • Mette Stie Kallesøe
    Lecturer
    Senior Principal Professional, Deputy QPPV
    LEO Pharma A/S
  • Annemette Geertsen
    Lecturer
    Global Regulatory Affairs Manager
    Ferring Pharmaceuticals A/S
  • Hanne Brokopp
    Lecturer
    NDA Principal Consultant
    Atrium
  • Mette Due Theilade Thomsen
    Lecturer
    Managing Director
    PIP Adviser
  • Wim Dartee
    Lecturer
    Global Lead Combination Products and Medical Devices, Regulatory Affairs at Novartis Pharma AG
    Novartis Pharma Schweiz AG
  • Samuel David Ramsden
    Lecturer
    Head of Risk Management Office
    Boehringer Ingelheim Pharma GmbH & Co. KG
See all

IS THIS COURSE FOR YOU?

Whether you are new to the field or have several years of experience, this course is relevant if you are a Regulatory Affairs Professional who wants to improve your knowledge and skills.

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

Course calendar

Starting 8 Mar 2023
8 Mar 2023 8:15-17:30

DAY 1

  • Welcome and introduction
  • The EU Variation System
  • Variation classification
  • Quiz
  • Variations - Experiences from “real-life”-Industry angle
  • New indications, extensions and renewals
  • Change control systems and how to be regulatory compliant
  • Group work
9 Mar 2023 8:15-16:30

DAY 2

  • Short summary of day 1 and introduction to day 2
  • Risk Management plans and PSURs
  • Implementation of Pharmacovigilance legislation - Impact on RA
  • Repeat use
  • Quiz
  • Maintenance of the EU product information
  • Group work
  • Rounding off day 2
10 Mar 2023 8:15-16:30

DAY 3

  • Short summary of day 2 and introduction to day 3
  • Paediatric regulation
  • Referrals
  • Intellectual properties
  • Group work
  • Summary of the Product Life Cycle module
Practical information

Related exams

11 Apr 2023 10:00-13:00
Go to exam page

Registration

Registration deadline
8 Feb 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
8 - 10 Mar
Sometimes things change. This is the expected programme.

Course information

Literature

Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

The mandatory readings are also part of the examination syllabus.

Prerequisites

To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in regulatory affairs, or other equivalent qualifications. We consider all applications upon registration.

If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 20% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs. We consider applicants on a case-by-case basis.

Examination

The exam is held online, usually 4-6 weeks after the course.

 You will receive a link with exam questions via your personal Atrium log-in.

 In order to participate in the exam, you must have attended the course.

This course is a part of this programme

Regulatory Affairs Diploma

The regulatory affairs diploma gives you an understanding of the entire ‘regulatory affairs platform’ of the medicinal product lifecycle. All courses have been designed in collaboration with highly acclaimed experts, that are on our regulatory affairs faculty board

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Course leader(s)

Dorte Bjørn-Larsen
Senior Regulatory Affairs Manager
Novo Nordisk A/S
Christina Rindshøj
Senior Director
Ozack ApS

Lecturer(s)

Peter Bachmann
Head International Liaison Office and Conferences, Executive Department European Union and International Affairs
German Federal Institute for Drugs and Medical Devices (BfArM)
Anna Silke Hammerbacher
Director Regulatory Strategy
Atrium
Ingrid Prieschl
Regulatory Consultant
Zwiers Regulatory Consultancy BV
Lilia Nicolaeva Lisdorf
Project Lead, Global Regulatory Affairs
FERRING PHARMACEUTICALS A/S
Anne-Sofie Thøger Andersen
Regulatory Specialist, Product Lead
Novo Nordisk A/S
Mette Stie Kallesøe
Senior Principal Professional, Deputy QPPV
LEO Pharma A/S
Annemette Geertsen
Global Regulatory Affairs Manager
Ferring Pharmaceuticals A/S
Hanne Brokopp
NDA Principal Consultant
Atrium
Mette Due Theilade Thomsen
Managing Director
PIP Adviser
Wim Dartee
Global Lead Combination Products and Medical Devices, Regulatory Affairs at Novartis Pharma AG
Novartis Pharma Schweiz AG
Christina Rindshøj
Senior Director
Ozack ApS
Samuel David Ramsden
Head of Risk Management Office
Boehringer Ingelheim Pharma GmbH & Co. KG

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WANT TO KNOW MORE or need help?

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

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