Webcast series covering legal framework, country-specific requirements and more
Webcode 24062050
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
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.
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.
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.
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.
Diego A. Salas
FIFARMA Latin America Federation of the Pharmaceutical Industry, COSTA RICA
Regulatory Affairs Director
10-11/06/2024
10-11/06/2024
Day one: Webcasts 1-3: 09:00-11:00, 12:00-14:30 and 15:00-17:00 CEST
Day two: Webcasts 4+5: 12:00-14:00 and 15:00-17:00 CEST
online
online
Event - 1,590 € plus tax
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support, including a test meeting.
Event - 1,590 € plus tax
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support, including a test meeting.
Nadja Wolff
Conference Manager
+49 6221 500-696
n.wolff@forum-institut.de
Regulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the stringent standards set by the EU/ICH regions. Join us in five consecutive webcasts to gain insights into local pharmacovigilance systems in different countries and regions, and learn how to integrate them into your global PV system while maintaining a clear overview!
International pharmaceutical manufacturers, depending on the region, face different regulatory requirements. In the field of pharmacovigilance, risk management for pharmaceuticals in emerging markets often competes with the stringent standards set in the EU/ICH regions. The diverse and relevant regulations of individual countries or regions require a finely tuned balance, ensuring that all local pharmacovigilance systems used by a company are integrated into a unified and truly global pharmacovigilance matrix.
Our experts provide you with a comprehensive update on the current legal and regulatory landscape, with a focus on your responsibilities related to the following:
This series of five webcasts deepens your understanding of the requirements and conditions in China, LATAM, the EAEU and MENA. In addition to the regulatory aspects, you will also become acquainted with intercultural considerations, providing you with a global overview of your pharmacovigilance system.
After the webcast series, you will be better equipped to comprehend local pharmacovigilance systems in emerging countries and regions. Furthermore, you will know how to integrate them into your global PV system and maintain an overview.
08:45
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
12:00 - 14:00
Dr Tanja Peters
14:00 - 15:00 Working break
15:00 - 17:00
Diana Gonzalez, Diego A. Salas
17:00 Webcast series ends
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Webcast blocks separated by 1 hour is an excellent structure.
