FORUM · Institut für Management GmbH
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Course Known Substances
Known Substances
Regulatory Strategies in Europe,
the Middle East and Russia/the EAEU
2019-10-02 2019-10-02 Heidelberg Marriott Hotel Vangerowstr. 16 69115 Heidelberg +49 6221 908-0 +49 6221 908-660

Known Substances - Regulatory Strategies in Europe, the Middle East and Russia/the EAEU

Regulatory affairs for drugs, herbal medicinal products, food supplements, borderline products etc.

After having attended this course you know how to enter the Middle Eastern, European and Russian markets with your herbal product, food supplement, generics or borderline product
  • Generic, bibliographic and hybrid applications in Europe
  • Borderline products in Europe, the Middle East and Russia/the EAEU
  • Food supplements, herbals, nutraceuticals - the possibilities
  • Value added generics and OTCs in the Middle East
  • Literature-based marketing authorisations outside the ICH region

Aims and objectives

Do you want to evaluate the options available for launching your product containing a known substance in new markets? This seminar will cover the legal basis and marketing authorisation options in Europe, the Middle East and Russia/the EAEU. Three local experts will guide you in building the ideal strategy for your product in the respective market, be it a generic, OTC product, borderline product, food supplement or herbal medicinal product.

This seminar will give you a thorough understanding of the European, Russian and Middle Eastern markets, enabling you to develop your own strategy.

Who should attend
This seminar addresses the needs of regulatory affairs managers dealing with known substances and working in the European, Middle Eastern or Russian/EAEU markets.

Medical affairs and business development managers aiming to enter one of these markets with their products will also find it helpful.
Your speakers
Markus Ambrosius
Sträter Lawyers, Bonn, GERMANY

Dr. Edelgard Rehak
Dr Edelgard Rehak Consulting, GERMANY

Mohammed Saleem, PhD
Boehmert & Boehmert, Representation Office Middle East and North Africa, JORDAN

Go forward

Electronic Regulatory Submissions in the Middle East

Booking Option

Electronic Regulatory Submissions in the Middle East on 1 October 2019

This course focuses on:

  • CTD requirements in Saudi Arabia, the UEA, Oman, Jordan and the GCC
  • eSubmission portals: Do they work?
  • What to keep an eye on: fees, validation issues, ...
  • Agents' capabilities in e-services
  • Current RA operational models in the MENA region


Pharma Webcast Global RA & PV

Pharma FORUM Webcast International

We would like to invite you to join our live webcasts, where local regulatory affairs and vigilance experts will inform you every two months of the latest news and trends in global marketing authorisation and drug safety.


More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2017 - 09.2018 produced a result of 1.6 (based on a school grading system of 1-6).