December 4, 2013
Pharmacovigilance: ADR Management and Reporting & Outsourcing Trends
During this webinar the following points will be discussed:
Adverse Drug Reaction Management and Reporting
- Key Requirements
- Timeliness for expedited reporting
- Reporting to EudraVigilance
- Tools and internal industry solutions for being compliant with regulations
Pharmacovigilance Outsourcing Trends
- Benefits and challenges involved in outsourcing pharmacovigilance processes
è Advantages and disadvantages of outsourcing
è Choosing a pharmacovigilance provider
è Working with your PV provider
è Ensuring oversight of out-sourced activities
- Brief insights into the role of pharmacovigilance throughout the product lifecycle from clinical development to patient care
- Presenting a PSUR to external regulatory authorities
èCompleting the risk-benefit analysis
A live Q&A with the audience will follow the main presentation.
|THIS PROGRAM IS INTENDED FOR|
VPs, Directors, Department Heads, Managers, Principal Scientists working within:
- Clinical R&D
- Clinical Research
- Pharmacovigilance and Drug Safety
- ADR Management
- Regulatory Affairs
- Medical Affairs
- Clinical Trial Safety
- Global Safety & Vigilance
Dr. Marcin Marciniak, Director Drug Safety & Pharmacovigilance, PregLem SA, and member of Gedeon Richter Group
Dr. Marciniak is a highly versatile executive with extensive sales & marketing, scientific and business development experience. He joined PregLem SA in 2010, where he is responsible for supporting a European Centrally Authorized Product registration, management of drug safety with products in early development and establishing a company-wide post-authorization pharmacovigilance system. Currently, he is responsible for drug safety & pharmacovigilance, including signal detection, medical writing, supporting regulatory variations and other aspects related to a Centrally Authorized Product and continuing drug development.
Dr. Marciniak moved into the headquarters and relocated to Switzerland, initially working on vaccine pharmacovigilance prior to joining PregLem SA. Previously, he has proven skills in sales & marketing in numerous therapy areas progressing to business unit manager, after which he decided it was time for a change of scenery and moved into research & development. This is where he started his journey in Pharmacovigilance. Being a self-motivated and talented leader, he was assigned multiple responsibilities interfacing with the Hungarian national regulatory and F. Hoffmann-La Roche Ltd global pharmaceutical projects. Dr. Marciniak was born and raised in Poland and studied and received his medical degree and doctoral degree from the Hungarian Medical University in Szeged.
Dr. Philip Jones, BMBS, MA, MSc, PhD, Associate Director & Deputy QPPV, Symogen Limited
Dr. Jones is Associate Director of Pharmacovigilance and Deputy QPPV at Symogen Limited. He is responsible for managing a team to deliver full pharmacovigilance services to a large pharmaceutical company. His role includes ensuring that high quality periodic reports are submitted on time to regulatory authorities, and ensuring that continuous signal detection and safety evaluations are performed to the highest standards to ensure patient safety. His previous role as Deputy QPPV for Aspen Pharma involved in-sourcing and setting up a new pharmacovigilance department, so he has valuable insights into the pros and cons of in-sourcing and out-sourcing PV activities.
Dr. Jones obtained his MA in Natural Sciences from Cambridge University, and his PhD in pharmacology from Bristol where he developed novel antagonists of metabotropic glutamate receptors. Following post-doctoral research at the NIH and McMaster, he obtained his BMBS from Nottingham and spent several years in clinical practice before joining the pharmaceutical industry as a pharmacovigilance physician.