Italian Pharmacovigilance Day
The evolution of the pharmacovigilance system: present and future challenges
Although five years have passed since July 2012, when the regulatory framework on medicinal products safety is revolutionized and strengthened, the evolution of the pharmacovigilance system has not yet stopped and there have been, and are still today, revisions and First-rate updates (GVP).
For AIC Holders, the challenges to be overcome are many, whether they belong to "big or small pharma", and whether pharmacovigilance activities are carried out at Mother Case, branch offices, or delegates to third parties. Therefore, pharmacovigilance is not just a mere gathering of adverse drug reactions, it is also an efficient organization of data and processes, with increasing attention to software solutions, supplier management, and quality control. This is also reflected in the upcoming changes in the EudraVigilance system, the implementation of the ICH-E2B (R3) format, the access of AIC holders to EudraVigilance. In addition, with the new dictionary produced by EMA and the European Regulation on Clinical Trials of Medicines, there will still be plenty of opportunities to test.
During the event, these challenges will be addressed through the analysis of some global processes, interaction between functions and activity monitoring.
Scientific Board
Raffaele Di Marzo, EU QPPV at Kedrion Antonia Pascale, Head of GVP & CSV Quality Assurance at Angelini Lisa Stagi, Drug Safety & Quality Head at Roche
During the conference, the Scientific Board, together with Dr. Daniela Marcozzi, Vice President Quality Assurance & Compliance Consultancy; Vice President PharmacoVigilance Services - PM Clinical Ltd, will lead a panel of experts from regulatory authorities, pharmaceutical companies and service companies to make this day an opportunity to discuss and discuss current and future pharmacovigilance challenges.
Target audience
The event is dedicated to all those who work under the Pharmacovigilance and play a role in the implementation and maintenance of the pharmacovigilance system, including interaction processes and quality system. Therefore, it may be of particular interest to professionals belonging to the various compartments that contribute to the fulfillment of regulatory requirements in Pharmacovigilance. Google Translate for Business:Translator ToolkitWebsite TranslatorGlobal Market Finder
Agenda
Wednesday November 8, 2017 - Rome Scientific Board:
Raffaele Di Marzo, EU QPPV at Kedrion Antonia Pascale, Head of GVP & CSV Quality Assurance at Angelini Lisa Stagi, Drug Safety & Quality Head at Roche
The times shown are temporary and may vary. More information will be available shortly 10:00 - 10:30 Registration and welcome coffee
10:30 - 10:40 Welcome to the Scientific Board
Raffaele Di Marzo - EU QPPV at Kedrion Daniela Marcozzi - Vice President Quality Assurance & Compliance Consultancy at PM Clinical Ltd Antonia Pascale - Head of GVP & CSV Quality Assurance at Angelini Lisa Stagi - Drug Safety and Quality Head at Roche - Pharmacovigilance in interventional studies: Future Challenges
Stefania De Santis - Director, PharmacoVigilance Services at PM Clinical LTD
Location
More information will be available shortly - Rome, Italy
Reference
https://italianpharmacovigilanceday2017.eventify.it/
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2,617 days ago- View all verifications
