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Seminar Electronic Regulatory Submissions in the Middle East
Electronic Regulatory Submissions
in the Middle East
2019-10-01 2019-10-01 Heidelberg Marriott Hotel Vangerowstr. 16 69115 Heidelberg hdbmc.reservations.office@marriott.com +49 6221 908-0 +49 6221 908-660

Electronic Regulatory Submissions in the Middle East

eSubmission in Saudi Arabia, the GCC, Oman, the UAE, Bahrain and Jordan - Legal, technical and commercial aspects

eSubmission in Saudi Arabia, the GCC, Oman, the UAE, Bahrain and Jordan. Learn about what is required for the submission portal.
Topics
  • eCTD 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

Aims and objectives

eCTD is the mandatory dossier format in many countries in the Middle East. Therefore, eSubmission becomes important. In most cases, a national partner is required for submission here. This course helps you avoid process interruptions and validation issues, and provides advice on how to best collaborate with your local agents to ensure the marketing authorisation is granted and maintained.
Who should attend
This unique course addresses the needs of employees in the healthcare industry involved in registering and maintaining marketing authorisations of drugs in MENA countries. Regulatory operations and regulatory affairs managers in particular will benefit from the speakers' expertise.
Your speakers
Mohammed Saleem, PhD
Boehmert & Boehmert, Representation Office Middle East and North Africa, JORDAN

Ala'a Saleem
Science Forum (SIPS), Amman, JORDAN


Go forward

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

Booking option

Known Substances - Regulatory Strategies in Europe, the Middle East and Russia/the EAEU on 2 October 2019

This course focuses on:

  • Generic, bibliographic and hybrid applications in Europe
  • Borderline products in Europe, the Middle East and Russia
  • Food supplements, herbals, nutraceuticals - the possibilities
  • Value added generics and OTCs in the Middle East
  • Literature-based marketing authorisations outside the ICH region

Details

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.

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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).

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