Summary
Module 9
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 & lecturers
- Christina Balslev RindshøjCourse leaderSenior Director
Ozack ApS - Dorte Bjørn-LarsenCourse leaderSenior Regulatory Affairs Manager
Novo Nordisk A/S
Is this course for you?
This course is for you if you are an experienced Regulatory Affairs professional, employed in the industry, a regulatory agency, or a consulting firm.
What you will learn
- The basic regulatory requirements for pharmaceutical products in the post-approval phase and regulations concerning pediatrics, risk management plans, referrals and generics
- How and when to apply for variations for CMC changes, labeling updates, SPC updates and renewals
- 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
- How to advise and decide on the optimal regulatory strategies for life cycle management projects
What your company will get
- 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
- A regulatory professional who knows how and when to apply for variations
- 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
- A regulatory affairs professional who is able to advise and decide on the optimal regulatory strategies for life cycle management projects
Course calendar
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
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
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
Registration
Registration deadline13 Mar 2024
Lersø Parkallé 101
2100 København Ø
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 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 10% 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 a diploma
The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.
Read moreCourse leaders
Ozack ApS
Novo Nordisk A/S
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