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Pharma / Medical devices
MR & Decentralised Procedure - Your Regulatory Strategy
MRP & DCP - Your options and challenges in practical exercises

MR & Decentralised Procedure - Your Regulatory Strategy

Bonn / 16.09.2014

Seminar regarding MRP + DCP - accelaration and delaying factors / Mutual Recognition Procedure + Decentralised Procedure - beschleunigende und verzögernde Faktoren im Verfahren[more]

Bonn / 16.09.2014
Marketing Authorisation in the Middle East
A hands-on seminar with two local experts from Jordan and Oman/GCC

Marketing Authorisation in the Middle East

Frankfurt / 06.10.2014

In this seminar you will be informed about the new regulatory affairs and pharmacovigilance legislation in the Middle East region. [more]

Frankfurt / 06.10.2014
English in Clinical Trials
for Clinical Research Associates and Clinical Trial Assistants

English in Clinical Trials

Frankfurt / 21.10.2014 - 22.10.2014

English in Clinical Trials[more]

Frankfurt / 21.10.2014 - 22.10.2014
Super-Generic Workshop

Super-Generic Workshop

Oman / Muscat / 28.10.2014

Super-Generic Workshop[more]

Oman / Muscat / 28.10.2014
Marketing Authorisation in ASIA
China, Indonesia, Singapore, Thailand, Korea, Malaysia, The Philippines, Vietnam, Taiwan

Marketing Authorisation in ASIA

Frankfurt / 28.10.2014 - 30.10.2014

Basic and advanced know-how on the current regulatory framework of the various countries will be addressed in this seminar.[more]

Frankfurt / 28.10.2014 - 30.10.2014
Oncologia: dagli studi clinici all'accesso al mercato

Oncologia: dagli studi clinici all'accesso al mercato

Milano / 28.10.2014 - 29.10.2014

Oncologia: dagli studi clinici all'accesso al mercato[more]

Milano / 28.10.2014 - 29.10.2014
Essentials of Medical Device Submission

Essentials of Medical Device Submission

Oman / Muscat / 29.10.2014 - 30.10.2014

Essentials of Medical Device Submission[more]

Oman / Muscat / 29.10.2014 - 30.10.2014
Marketing Authorisation for Human Medicines in Latin America
Focus: Brazil, Argentina, Colombia & Mexico

Marketing Authorisation for Human Medicines in Latin America

Frankfurt / 05.11.2014

Arzneimittelzulassung in Lateinamerika - Kompaktseminar mit lokalen Experten[more]

Frankfurt / 05.11.2014
CMC Biopharmaceutical and Market Access

CMC Biopharmaceutical and Market Access

Oman / Muscat / 10.11.2014 - 11.11.2014

CMC Biopharmaceutical and Market Access[more]

Oman / Muscat / 10.11.2014 - 11.11.2014
International Pharmacovigilance Conference

International Pharmacovigilance Conference

Milano / 13.11.2014

International Pharmacovigilance Conference[more]

Milano / 13.11.2014
Monoclonal Antibodies - From Originators to Biosimilars
Quality, (pre-)clinical development & marketing authorisation

Monoclonal Antibodies - From Originators to Biosimilars

Frankfurt / Offenbach / 20.11.2014 - 21.11.2014

Join this seminar for an update on international regulatory framework for originator and biosimilar antibodies.[more]

Frankfurt / Offenbach / 20.11.2014 - 21.11.2014
Marketing Authorisation in North & South Africa
Regulatory Update - The Maghreb Countries & South Africa

Marketing Authorisation in North & South Africa

Frankfurt / 24.11.2014

This seminar gives you a thorough update on the regulatory requirements in Tunisia, Algeria, Morocco and South Africa (marketing authorisation and maintenance).[more]

Frankfurt / 24.11.2014
RUSSIA: Registration of Generics and Biosimilars
Local bioequivalence and tox studies required!

RUSSIA: Registration of Generics and Biosimilars

Berlin / 30.01.2015

Since the introduction of Federal Law 61 in 2010 for registrations of medicinal drug products in Russia, local clinical trials have been mandatory. This seminar informs you on your duties when registering a generic or biosimilar...[more]

Berlin / 30.01.2015
CMC Documentation & Post-Approval Changes/Variations

CMC Documentation & Post-Approval Changes/Variations

Frankfurt / 04.03.2015 - 05.03.2015

This conference addresses quality-related questions from the the CTD compilation to quality changes/variations.[more]

Frankfurt / 04.03.2015 - 05.03.2015
ExpertFORUM Regulatory Affairs
Towards a faster and more tailored marketing authorisation in Europe and in the US?

ExpertFORUM Regulatory Affairs

Frankfurt / 05.03.2015

This course addresses your regulatory strategy (the EU and the US) - does it fit with the HTA-requirements?[more]

Frankfurt / 05.03.2015
Regulatory Affairs India
Marketing Authorisation in India/Arzneimittelzulassung in Indien

Regulatory Affairs India

Frankfurt / 18.03.2015

Current challenges in regulatory affairs (focus marketing authorisation and maintenance) - addressed by experts with local know how[more]

Frankfurt / 18.03.2015
Regulatory Affairs China

Regulatory Affairs China

Frankfurt / 19.03.2015

Current challenges in regulatory affairs (focus marketing authorisation and maintenance) - addressed by experts with local know how[more]

Frankfurt / 19.03.2015
FDA: Marketing Authorisation in the U.S.

FDA: Marketing Authorisation in the U.S.

Köln / 03.04.2015

This seminar adresses the essentials regarding a FDA drug registration with a focus on the application procedure and the communication with the authority.[more]

Köln / 03.04.2015
Scientific Writing and Reviewing in Regulatory Affairs
Update your English writing skills!

Scientific Writing and Reviewing in Regulatory Affairs

Frankfurt / 27.04.2015 - 28.04.2015

After completing this seminar, participants will be aware of the key regulatory requirements when preparing texts, with a greater awareness of the importance of proper English writing, reviewing and proofreading processes.[more]

Frankfurt / 27.04.2015 - 28.04.2015
Marketing Authorisation in Turkey and the CAC Countries
Focus: Kazakhstan, Georgia, Azerbaijan and Uzbekistan

Marketing Authorisation in Turkey and the CAC Countries

Berlin / 08.05.2015

Regulatory affairs requirements in Turkey, Kazakhstan, Georgia, Azerbaijan and Uzbekistan are explained at this seminar in detail.[more]

Berlin / 08.05.2015
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