Eventi Internazionali

Corsi di formazione in lingua Inglese su tematiche di respiro internazionale, organizzati dal nostro partner di formazione, il Forum Institut für Management GmbH. Gli speaker prescelti hanno provenienza europea.

Elenco corsi

The Pharmacovigilance System Master File (PSMF) in a Global Environment

Core PSMF vs local annexes: Dos and Don'ts
dal 26/02/2024 al 26/02/2024
09:00 - 17:00
Mara Dinkel, Senior Expert Pharmacovigilance, Mainz, GERMANY

Heike von Treichel, Senior Expert Pharmacovigilance, Darmstadt, GERMANY
  • Concept of a global PSMF
  • Structure and content of a core PSMF
  • Local annexes - practical hints and pitfalls
  • Effective maintenance: Impact assessment, ad-hoc updates and change control
  • QPPV oversight vs. local PV officer

Regulatory and GMP compliance in Eastern Europe

- Online Training -
dal 15/04/2024 al 16/04/2024
09:00 - 16:00
Dr. Edelgard Rehak, Dr Edelgard Rehak Consulting, GERMANY 

Michael Faust, EXTEDO GmbH, GERMANY
  • EAEU pharmaceutical market:
    Regulatory Status quo
  •  Registration of new drugs in the EAEU
  • Variations in the EAEU
  •  CMC documents for marketing authorisation
  •  ... and many more topics

Drug Market Access & Pricing in Europe

Online seminar on Payer Contracts, HTA process and Tender management
dal 22/04/2024 al 23/04/2024
9:00 - 15:00
Dr. Thomas Ecker, Ecker + Ecker GmbH, Hamburg

Graham Foxon Ph.D. MBA, Remap Consulting UK Ltd, Cheshire, GREAT BRITAIN

Dr Alicia Gil, OMAKASE Consulting S.L., Barcelona

Fabio Kistner, Simon-Kucher & Partners Strategy & Marketing Consultants GmbH

Dr Entela Xoxi, Research fellow at Università Cattolica del Sacro Cuore - School of Health Economics and Management (ALTEMS):
  • Reference Pricing in Europe
  • Payer-Archetyping
  • Market Access and Pricing in France, Italy, Spain, Germany and the UK
  • Specialties with regard to ATMPs/Gentherapeutics
  • HTA process and the role of RWE in the HTA context

Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

5 webcasts in two days: Legal framework, Country-specific requirements and more
dal 10/06/2024 al 11/06/2024
10/06/2024 09:00 - 17:00 11/06/2024 12:00 - 17:00
Yingxia Zhang, Boehringer Ingelheim, CHINA

Yanjie Shen, Boehringer Ingelheim, CHINA

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

Dr. Edelgard Rehak, Dr Edelgard Rehak Consulting, GERMANY

Dr. Tanja Peters, Merck HealthCare KGaA, Darmstadt, GERMANY

Diana González, FIFARMA Latin America Federation of the Pharmaceutical Industry Roche S.A, COLOMBIA 

Diego A. Salas, FIFARMA Latin America Federation of the Pharmaceutical Industry, COSTA RICA
  • Legal framework in ed (emerging) countries or regions
  • Similarities and differences in ADR collection and reporting compared to EMA standards
  • Country-specific requirements for PSMF, PSURs and RMPs
  • How to integrate local PV systems into a global system
  • Special focus on China, LATAM, EAEU and MENA