Hot Topic: Challenges for global Regulatory Strategies beyond the EU, US and Japan

Learn the most crucial regulatory issues when defining global regulatory strategies incorporating multiple geographical regions along drug development and product lifecycle

  • 28. Nov 2019

1 day course

Danish

3.800,- DKK ex VAT
(app. 511,- EUR ex VAT)

Summary

Countries or regions outside the EU, USA and Japan are major focus areas for potential business growth, also within the healthcare sector. Today, many of those are members or observers of the ICH (The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use). However, there are still many local country specific regulatory guidelines and legislative requirements causing regulatory challenges. Such country specific requirements can strongly affect a clinical development program and the regulatory strategy for new drugs, as much as they are determining approvals and life cycle management activities to a large extent.

This hot topic seminar will provide a high-level overview on key challenges for global drug development, worldwide product roll out and life cycle management plans incorporating multiple geographical regions. While previous seminars looked at defined key countries, the basis of this hot topic seminar is the global development plan and the regulatory strategy linked to this with focus on dedicated regulatory areas with country specific requirements, such as clinical development, CMC, Life Cycle Management, labelling and launch activities etc.

For each topic the most specific countries and/or requirements impacting the underlying regulatory strategies across different geographies will be outlined.

After this seminar, you will have an overview of the most important regulatory challenges in growth markets outside the EU, USA and Japan across the different drug development and life cycle stages.

You will gain insight on business-critical aspects when operating in a complex global regulatory environment, which will help you, strengthen your regulatory strategies.

KeYwords

Challenges for global regulatory strategies
Multiple geographical regions
Crucial regulatory issues to be aware of
Growth markets outside the EU, USA and Japan

What you will learn

  1. An understanding of the challenges you will meet when incorporating multiple geographical regions in your global regulatory strategy
  2. The most crucial regulatory issues to be aware of when defining global regulatory strategies
  3. The most crucial country specific requirements in dedicated areas, such as clinical development, CMC, Life Cycle Management, Labelling and Launch activities etc.

What your company will get

  1. An employee who has an overview of the most important regulatory challenges in growth markets outside the EU, USA and Japan across the different drug development and life cycle stages
  2. An employee with insight on business-critical aspects when operating in a complex global regulatory environment, which will help strengthen your regulatory strategies
  3. An employee with awareness of potential impact on submitted and approved reference dossiers (initial application and life cycle management) in EU, USA and/or Japan.
Available start dates
All course dates: 28. Nov 2019

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.comRead our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Director Søren-Ulrik Fangholm at +45 39 15 09 45

Send an email

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