Ala'a Saleem
Science Forum (SIPS), Amman, Jordan
Deputy General Director "Technical Affairs"
More information please click here.
Karin van der Auwera
Intercultural Communication Training, Germany
Karin van der Auwera studied English and German at the University of Stuttgart and at Tulane University, New Orleans. For six years she ran a private language school in Stuttgart. Since 1989 she has been training business professionals teaching international communication and cultural competence. Karin van der Auwera's clients include a broad range of multi-national companies throughout the European Union and the USA.
More information please click here.
Alessandra Zago
Boehringer Ingelheim International GmbH, Ingelheim, Germany
Regional PV Head Africa & Asia Alessandra has 16 years of experience in Pharmacovigilance. She worked for Sanofi and Boehringer Ingelheim in Brazil where she acted as PV Head and Qualified person for local HA being responsible to stablish and maintain a PV system compliant with emergent local legislations and global standards. Since Mar 2019, as a Regional PV Head located in Germany, she is responsible for PV in China, South East Asia and South Korea, India, Middle East and Africa countries. In this period, she actively contributed to the implementation of new regulatory requirements of emerging markets such as the Institutional Reform of China State Council.
Anna Kramar
Eisai LLC, Moscow, Russia
Medical Director; Anna has more than 15 years of experience in Pharmaceutical industry in Regulatory affairs and about 8 years in PV. She has background in Organon, Bayer-Schering and Sanofi. After joining Eisai Russia she had to build PV system from the scratch and reform it after EAEU GVP introduction. PV system successfully passed several internal audits.
Raphael Pareschi
MSD, Sao Paulo, Brazil
Associate director and back-up of PV Country Lead in Brazil Raphael has more than 10 years of experience in Pharmacovigilance, beginning his career at Sanofi, where he acted in roles of increasing responsibility within local PV organization, responsibilities included oversight of case management, PSUR management to comply with Brazilian regulation and RMP management. He served as Deputy for PV Head in Sanofi Brazil, Genzyme, Sanofi Pasteur (vaccines) and Medley (generics) Raphael also worked for Johnson & Johnson for 2 years as associate manager, with responsibility for 18 countries within Latin America in processes like PSURs management to comply with LatAm requirements, PV Agreements management, oversight of expedited reporting to Health Authority and of contracts with vendors and business partners related to Pharmacovigilance. The activities are related to drugs, devices and cosmetics. Since January 2018 Raphael is working at Merck & Co (MSD) as Associate director and back-up of PV Country Lead in Brazil.
Dr. Tanja Peters
Merck HealthCare KGaA, Darmstadt, Germany
Head Global Patient Safety Neurology & Immunology; Dr Tanja Peters is a clinical pharmacologist with over 22 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.
27. - 28.06.2022
27. - 28.06.2022
Day 1: 9:00 a.m. - 5:00 p.m.Day 2: 9...
Day 1: 9:00 a.m. - 5:00 p.m.
Day 2: 9:00 a.m. - 5:00 p.m.
You may dial in 30 min. before the session
The times for breaks at online-seminars are scheduled individually.
online
online
Veranstaltung - 1.790,- € zzgl. MwSt.
The fee includes a comprehensive e-documentation including the possibility to download these documents and a certificate.
Veranstaltung - 1.790,- € zzgl. MwSt.
The fee includes a comprehensive e-documentation including the possibility to download these documents and a certificate.
Petra Birkenbihl
Conference Manager
+49 6221 500-696
p.birkenbihl@forum-institut.de
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 in this course will give you a detailed update on the current legal and regulatory background and on your duties.
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:
This seminar addresses the needs of people who work in the pharmaceutical industry. It will particularly benefit those dealing with international pharmacovigilance issues, such as
09:00
09:15
Alessandra Zago
11:00 Coffee break
11:15
Karin van der Auwera
12:30 Lunch break
13:45
Karin van der Auwera
15:15 Coffee break
15:30
Ala'a Saleem
16:30
17:00 Day one ends
09:00
Anna Kramar
11:15 Coffee break
11:30
Dr Tanja Peters
13:15 Lunch break
14:30
Raphael Pareschi
15:30 Coffee break
15:45
Raphael Pareschi
16:45
17:00 Seminar ends
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 via e-mail to s.wittemann@forum-institut.de
Overall impression: 100% of the participants’ feedback was very good or good. (June 2019)
Practical benefit:: 100% of the participants’ feedback was very good or good. (June 2019)
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Comment of former participants (June 2020)
My expectations were to get a refresher + information on recent developments in PV-requirements for all anounced markets; my expectations were fully met. Positive was the opportunity of immediate and direct interactions though we met only virtually.
Very useful and informative for people operating in emerging markets.
Very detailed information, well structured, fruitful discussions
Very helpful for our daily work and with view to new challenegs in emerging markets. I would like to introduce new ideas in my PV Team.
This is why the course in June 2019 met the participants' expectations:
New and good information on cultural differences and PV-requirements in the different countries. Methods to get an overview about the different PV-requirements (e.g. timelines for PSURs etc.).
Good overview of the newest regulations and reporting guidelines.