Module 15
This course will give you an understanding of the regulatory affairs environment for generic products and generic companies in the EU.
We will focus on the characteristics of generic products and the registration and marketing of generic products. You will also get an understanding of the differences between generic and originator applications.
You will be taken through the life-cycle of generic products from the development of the product through regulatory strategy, evaluation of the dossier and preparation of the marketing authorization application, as well as the post-authorization responsibilities linked to the product, such as pharmacovigilance and life cycle management.
In addition we will compare scenarios such as different challenges at the generic companies for own development products versus in-licensed products.
The module focuses on the current EU regulatory legislation and guidelines.
Keywords
- Definitions, requirements and socio-economics/ethics
- Challenges for generics
- Development of generic products
- Legal basis and procedures
- Strategy
- Application and content
- Clinical studies relevant for generics
- BE guidelines
- MAH responsibilities
- Future trends
- Advantages and challenges
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 on generic products.
What you will learn
- The background for generic products
- The possibilities in the legislation for obtaining marketing authorizations with abridged documentation
- How to advise and decide in bioequivalence studies
- How to analyze and evaluate on strategy and choice of regulatory procedure and reference product
What your company will get
- A regulatory professional who understands the characteristics of generic products
- A regulatory professional who can navigate within the regulatory affairs environment for generic products
- A regulatory professional who can advise and decide in bioequivalence studies
- An employee who can play an important strategic role in the analysis, evaluation and decision on regulatory procedure and reference product
Course calendar
DAY 1
- Introduction • Setting the scene – authority point of view
- Setting the scene – industry point of view
- Legal basis and procedures
- Development of generic products Strategy
- Application and procedure
- Workshop Day 1 – Strategy
DAY 2
- Clinical Studies
- BE guidelines
- Workshop Day 2 - Bioequivalence
- MAH responsibilities and cooperation with other functions – from a regulatory point of view
- Trends, future, advantages/ challenges
Registration
Registration deadline22. Dec 2021
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 as a minimum two years of experience in regulatory affairs, or other equivalent qualifications. We assess 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 usually held 4-6 weeks after the course. It is a digital exam, and you can therefore take the exam in your own country from any location that provides adequate internet access.
This course is a part of this programme
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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WANT TO KNOW MORE or need help?
Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30
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