Speaker Profile
MARCO SARDELLA
Marco Sardella, Chief Pharmacovigilance Officer EU-QPPV-ADIENNE Pharma & Biotech Dr. Marco Sardella is a PV Person with significant experience in setting up pharmacovigilance and risk management systems worldwide (experience with EMA, USA, Canada, Switzerland, Russian Federation, Asia, Middle East). Former European QPPV of Gentium S.p.A/Jazz Pharma. Today, overall Responsible for Global Safety and Pharmacovigilance for the Group ADIENNE Pharma and Biotech in the position of Chief Pharmacovigilance Officer & European QPPV. Experience with development of CTD safety modules for hemato-oncological products [successful approval in the US, Canada, (New Drug Applications) and EMA (Marketing Authorization Applications)]. Responsible for Safety in international pre-approval and post-approval safety studies.
Pragmatic Approach to Pharmacovigilance/Drug Safety System Update Against the Latest New Requirements
In the last year/recent months, there have been a lot of changes in the pharmacovigilance requirements especially impacting the reporting to EudraVigilance, the Signal Detection Management (e.g. inclusion of EudraVigilance Data Analysis System as part of the Signal Detection Management, etc.) and the Risk Management activities. The course is aimed at providing some practical examples of the application of t..