Global Regulatory Strategies

Regulatory strategic considerations during global drug development

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  • 15. Jan 2020

3 days course

English

14.300,- DKK ex VAT
(app. 1.923,- EUR ex VAT)

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Module 5

Summary

As a regulatory affairs expert, you play an active part in the entire drug development process. This is crucial if you wish to develop new and effective drugs, and at the same time meet the expectations of a faster and more efficient drug development process.

On this course, you will delve deep into regulatory decisions and strategies and get an in-depth understanding of how and why they are made. Regulatory courses normally focus on laws, guidelines, and directives, but offer little insight on the role of regulatory experts in project teams. Our course delves much deeper into the guidelines and explores the background of global regulatory strategies and the preceding considerations. If you are a regulatory affairs employee, then you will benefit greatly from this insight, which will be delivered by a number of internationally experienced lecturers.



Keywords

Regulatory Affairs Involvement in Product Development
Regulatory Strategies
Consultation with Authorities Throughout Development
Regulatory Intelligence
The Development of a Target Label
Regulatory Planning
Intellectual Property Rights
Pricing and Reimbursement Negotiations

What you will learn

  1. How to develop a regulatory strategy for products in various stages of the product life cycle
  2. How to analyze strengths and weaknesses of a product in order to develop regulatory strategies and target product profiles
  3. How to use best practices when communicating a regulatory strategy to the company project team or top management
  4. To operate in a dynamic and changing environment, where internal as well as external business partners and authorities must understand the rationale of the product development

What your company will get

  1. A regulatory professional who can play an active, effective and crucial part in the entire development and decision-making process
  2. A regulatory professional who can develop a regulatory strategy for products in various stages of the product life cycle
  3. A regulatory affairs professional who can communicate a regulatory strategy to the company project team or top management
  4. A regulatory affairs professional who can operate in a highly dynamic and constantly changing environment
Available start dates
All course dates: 15. Jan 2020, 16. Jan 2020, 17. Jan 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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