2023-06-04 2023-06-04 , online online, 1,190 € zzgl. MwSt. Ala'a Saleem https://forum-institut.de/seminar/23112450-cmc-requirements-in-mena-region/referenten/23/23_11/23112450-training-cmc-requirements-in-levant,-gcc,-turkey,-iran,-egypt_saleem-alaa.jpg CMC requirements in MENA region

Four live webcasts à 2 hours every week in November 2023: CMC requirements in Levant (Morocco, Tunisia, Jordan, Lebanon, Iraq), GCC, Turkey, Iran and Egypt. Meet our three experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!

Topics
  • Concept: Four weekly live webcasts à 2 hours with (local) experts
  • Regions covered: Levant, GCC, Iran, Türkiye, Egypt
  • Your benefits: Possibility to directly interact with the speaker;
  • You will receive a certificate after each session;
  • You are unable to attend one of the sessions? Benefit from the recording of each webcast!


Who should attend
This series will be of benefit to all those working in the pharmaceutical industry, particularly CMC and regulatory affairs managers, who are dealing with dossier compilation (quality data/module 3) for the regions Levant, GCC, Turkey, Iran and Egypt.

The webcast series will cover small and large molecules.
Aims and objectives
During this webcast series you will learn about the specific CMC requirements in Levant (Morocco, Tunisia, Jordan, Lebanon, Iraq), GCC, Türkiye, Iran and Egypt.

Three (local) experts will share valuable information regarding
  • pharmaceutical documentation,
  • country specific requirements and
  • avoidance of typical mistakes.

After the training course you will have gained a better understanding of the additional and differing CMC-related requirements and procedures in the different regions.
Your benefit

  • Meet three (local) experts that will share in-depth knowledge with you!
  • Obtain practical CMC know-how for emerging markets!
  • Integrate the webcast sessions conveniently into your daily work routine!
  • Missed a live session? No problem! Make profit from the recording that is available after each individual webcast!

Training course - CMC requirements in MENA regions

CMC requirements in
MENA regions

- Online training -

Benefits
  • First-hand information, local expertise
  • Pose your questions prior to the training
  • Four single webcasts à 2h - convenient to integrate into your work routine
  • We follow the IMI quality criteria

Webcode 23112450

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

anytime

anytime

Zeitraum

7 November, 14 November, 21 November...

7 November, 14 November, 21 November, 28 November 2023
live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Downloads
Gebühr
Ihre Kontaktperson

Dr. Birgit Wessels
Konferenzmanagerin Healthcare

+49 6221 500-652
b.wessels@forum-institut.de

Details

Four live webcasts à 2 hours every week in November 2023: CMC requirements in Levant (Morocco, Tunisia, Jordan, Lebanon, Iraq), GCC, Turkey, Iran and Egypt. Meet our three experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!

Topics
  • Concept: Four weekly live webcasts à 2 hours with (local) experts
  • Regions covered: Levant, GCC, Iran, Türkiye, Egypt
  • Your benefits: Possibility to directly interact with the speaker;
  • You will receive a certificate after each session;
  • You are unable to attend one of the sessions? Benefit from the recording of each webcast!


Who should attend
This series will be of benefit to all those working in the pharmaceutical industry, particularly CMC and regulatory affairs managers, who are dealing with dossier compilation (quality data/module 3) for the regions Levant, GCC, Turkey, Iran and Egypt.

The webcast series will cover small and large molecules.
Aims and objectives

During this webcast series you will learn about the specific CMC requirements in Levant (Morocco, Tunisia, Jordan, Lebanon, Iraq), GCC, Türkiye, Iran and Egypt.

Three (local) experts will share valuable information regarding

  • pharmaceutical documentation,
  • country specific requirements and
  • avoidance of typical mistakes.

After the training course you will have gained a better understanding of the additional and differing CMC-related requirements and procedures in the different regions.

Your benefit

  • Meet three (local) experts that will share in-depth knowledge with you!
  • Obtain practical CMC know-how for emerging markets!
  • Integrate the webcast sessions conveniently into your daily work routine!
  • Missed a live session? No problem! Make profit from the recording that is available after each individual webcast!

Detailed programme

7 November, 14 November, 21 November, 28 November 2023
live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts

Welcome and introduction


Q&As


End of webcast


Welcome and introduction


Q&As


End of webcast


Welcome and introduction


Q&As


End of webcast


Welcome and introduction


Q&As


End of webcast series


Ala'a Saleem

7 November 2023: CMC requirements in Levant and GCC
  • Overview of MENA region
  • Adaptation from EU and differences within MENA
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes in the dossier, common pitfalls
  • Future trends in the regions

Seda Kadioglu

14 November 2023: CMC requirements in Türkiye
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes in the dossier, common pitfalls
  • Future trends in the regions

Dr Makram Nehme

21 November 2023: CMC requirements in Iran
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes in the dossier, common pitfalls
  • Future trends in the regions

Dr Makram Nehme

28 November 2023: CMC requirements in Egypt
  • Pharmaceutical documentation
  • Additions and differences with regard to ICH requirements
  • Country specific requirements
  • Practical experiences (e.g. MAA, renewal, variations)
  • Avoiding typical mistakes in the dossier, common pitfalls
  • Future trends in the regions

More information

Webcast series: CMC requirements in Latin America (23042453)

You are working with affiliates or external partners in Latin America?

Three (local) experts will share their in-depth knowledge on CMC requirements in this region with you (focus Mexico, Brazil, Colombia, Argentina, Chile, Peru, CAMCAR (Central America and Caribbean) - webcasts scheduled weekly in April/May 2023.

For more information visit our website using the webcode 23042453.

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

  • You will find brief instructions on how to use Zoom, your course documentation, the access link and a meeting ID in your personal customer account.
  • Use a headset, loudspeakers or the telephone for audio.
  • Listen to the speaker and follow the presentation.
  • Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

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