Regulatory Challenges in Markets Outside the ICH Countries

Learn the most crucial regulatory issues in Russia, China, India, Mexico, and Africa in this one day hot topic seminar

  • 7. Dec 2017

1 day course

English

3.750,- DKK ex VAT
(app. 504,- EUR ex VAT)

Summary

There is a major potential for business growth in countries and regions outside the EU, the US, and Japan. Today, many of these countries and regions are observers of the ICH (The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), but there are still a number of local country specific regulatory guidelines and legislative requirements that cause additional regulatory challenges and influence the access of drugs to patients.

Country specific requirements can strongly effect a clinical development programme and influence the regulatory strategy, the approval process, and the life cycle management of a drug.
This hot topic seminar provides an overview of the key challenges for global drug development, for worldwide product launch, and for life cycle management plans.

Our focus is on pharmaceutical products and drug-device combinations (regulated as drugs). We will cover selected key markets representative for the different geographical regions including Russia, China, India, Mexico, and Africa.

After this seminar, you will have an overview of the most important regulatory challenges in growth markets outside the EU, the US, and Japan.
The seminar is relevant for employees in the pharmaceutical industry as well as CROs and service providers, health authorities, and others involved in development, approval and life cycle management of pharmaceutical products.
 

Keywords

Regulatory issues in markets outside the ICH
Potential impact towards submitted and approved reference dossiers
Regulatory affairs in Russia, China, India, Mexico, and Africa

What you will learn

  1. The key challenges for global drug development
  2. The most crucial regulatory issues to be aware of in the growth markets of Russia, China, India, Mexico, and Africa
  3. Insights on business critical aspects when operating in a complex global regulatory environment, which will help and strengthen your regulatory strategies
  4. Awareness about potential impact towards submitted and approved reference dossiers (initial application and life cycle management) in the EU, the US and/or Japan

What your company will get

  1. A professional who understands the key challenges for global drug development
  2. A professional who can play an important role in the strategic decisions for the potential growth markets outside the ICH
  3. A professional who is aware of the most crucial regulatory issues to be aware of in Russia, China, India, Mexico, and Africa
Available start dates

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 Carina Schaldemose Hansen, Digital Project Manager at + 45 39 15 09 22, or send her an email at csc@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 on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email

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