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EVENTS
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ABOUT US
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SERVICE
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LEARNING SPACE
Learning Space
China - LATAM - Russia - MENA
Webcode 23062053
Ala'a Saleem
Science Forum (SIPS), Amman, JORDAN
Deputy General Director "Technical Affairs"
15 years’ experience in different fields comprising RA and IPR in the pharmaceutical area. As a member of SIPSMENA team, Ala’a has been subjected to various other areas in the pharmaceutical industry such as agent selection, legal requirements, market access and others.
More information please click here.
Dr. Edelgard Rehak
Dr Edelgard Rehak Consulting, GERMANY
Dr Rehak is an expert on registration in Russia and Central and Eastern Europe. From 2011 to 2014, she worked as Regulatory Director at Sanofi and Medical Director at Zentiva, based in Moscow, and prior to that, from 2006 to 2009, as Head Regulatory and QA for Novartis, based in Kiev, Ukraine.
She has a broad range of experience in bioequivalence and toxicological trials in Russia. Until 2006, she held several positions in product development (Gx and biosimilars) and clinical research at Sandoz/HEXAL, Germany.
More information please click here.
Yanjie Shen
Boehringer Ingelheim, CHINA
PV Physician Yanjie has 5-years' working experience in China Pharmacovigilance at IQVIA, Celgene and Boehringer Ingelheim, and 4-years' working experience in nutritional products adviser and medical information handling at Sanofi, Roche Diagnostics and Eli Lilly.
Yingxia Zhang
Boehringer Ingelheim, CHINA
PV Associate Director; Yingxia has 12-years' working experience in China Pharmacovigilance at Sanofi and Boehringer Ingelheim from 2011, and 4-years' working experience in pre-clinical research at Stealth Peptides from 2007. Also is a member of China Quality Assurance Forum (CQAF) PV Working Group
Diana González
FIFARMA Latin America Federation of the Pharmaceutical Industry Roche S.A, COLOMBIA
Pharmacovigilance group leader for FIFARMA and Patient Safety Lead for Roche S.A.
Dr. Tanja Peters
Merck HealthCare KGaA, Darmstadt, GERMANY
Head Global Patient Safety Neurology & Immunology; Dr Tanja Peters is a clinical pharmacologist with over 25 years experience in pharmaceutical industry; She has worked in various positions in Research & Development, Regulatory Affairs and Pharmacovigilance at Merck KGaA and Boehringer Ingelheim. During her 8 years as Deputy EU-QPPV & Head PV Intelligence at Boehringer Ingelheim she implemented EU-GVP, developed the company’s PSMF, and built a PV Intelligence network in coorperation with the regional PV organisations to oversee, analyse and implement new pharmacovigilance requirements into local and global PV Systems.
Diego A. Salas
FIFARMA Latin America Federation of the Pharmaceutical Industry, COSTA RICA
Regulatory Affairs Director
12-13/06/2023
12-13/06/2023
Day one: Webcasts 1-3: 09:00-11:00, ...
Day one: Webcasts 1-3: 09:00-11:00, 12:00-14:30 and 15:00-17:00 CEST
Day two: Webcasts 4+5: 12:0-14:00 and 15:00-17:00 CEST
online
online
Event - 1,590 € plus tax
The fee includes a comprehensive e-documentation including the possibility to download these documents and a certificate.
Event - 1,590 € plus tax
The fee includes a comprehensive e-documentation including the possibility to download these documents and a certificate.
Dr. Myriam Friedel
Conference Manager
+49 6221 500-696
m.friedel@forum-institut.de
5 consecutive webcasts - Pharmacovigilance in China, LATAM, EAEU, MENA, Latin America and on strategic questions
Regulatory expectations around risk management for medicinal products in emerging markets are competing with the stringent standards set by the EU/ICH regions. The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix.
Our experts will give you a detailed update on the current legal and regulatory background and on your duties with regard to:
These 5 consecutive webcasts will bring you closer to the requirements and conditions in China, LATAM, EAEU and MENA. The event not only highlights the professional topics but also familiarizes you with intercultural aspects and thus offers you a comprehensive overview.
09:00 Day 1 begins
09:00 - 11:00
Yanjie Shen, Yingxia Zhang
11:00 - 12:00 Working break
12:00 - 14:30
Ala'a Saleem
14:30 - 15:00 Working break
15:00 - 17:00
Dr Edelgard Rehak
17:00 Day 1 ends
12:00 Day 2 begins
12:01 - 14:00
Dr Tanja Peters
14:00 - 15:00 Working break
15:00 - 17:00
Diana Gonzalez, Diego A. Salas
17:00 Seminar ends
Overall score of all evaluations in 2022
Five stars on Trustpilot = Excellent
Our global and local experts will update you every two months with the latest regulatory and legislative developments. T...
Do you need essential European regulatory affairs knowledge? This online training course gives you a compact overview on...
The latest on EU digital programmes (PLM, SPOR, ePI, etc.) and implementation in your sector.
During this summer school you will build a solid toxicological know-how basis and will be informed about the inclusion o...
The e-learning provides a comprehensive understanding of the German healthcare system, market access and reimbursement o...
Good overview of the newest regulations and reporting guidelines.
A highly recommended seminar for every PV employee who works with international PV partners and needs to have deeper knowledge about PV requirements in these regions.
Interesting and innovative in order to understand the new PV requirements.
I really enjoyed the whole training. Really very good, the comparison between regions and the EU.
Very good topic, very interesting and exciting.
Excellent overview of reporting requirements.
