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

08:30 Uhr Registrierung;
09:00-17:00 Uhr Seminar

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.


Heidelberg Marriott Hotel
Vangerowstraße 16
69115 Heidelberg


FORUM Institut für Management GmbH

Sträter Rechtsanwälte
Kronprinzenstraße 20
D-53173 Bonn

Fon +49 (0) 228 93454-0
Fax +49 (0) 228 93454-54



Markus Ambrosius, Partner

Rechtsanwalt Markus Ambrosius ist Partner der Kanzlei. Er ist intensiv im Arzneimittelrecht tätig und berät dabei hauptsächlich Arzneimittel- und Medizinproduktehersteller in allen regulatorischen Fragestellungen und vertritt diese auch in verwaltungsgerichtlichen Verfahren. Rechtsanwalt Ambrosius ist Lehrbeauftragter der Universitäten Bonn und Marburg.