Jean Christophe DelumeauHead of Pharmacovigilance Asia Pacific & China
Bayer South-East Asia (Singapore)
Originating from France, Jean-Christophe Delumeau graduated in medicine, toxicology, pharmacology, applied statistics and methodology of clinical trials, from universities of Rennes and Paris. From 1986, after completing residency, he joined Jacques Glowinski's laboratory, part of the French national institute of medical research (inserm), at the College de France in Paris. There, he developed microfluorimetry i.e. the use fluorescent probes for monitoring the concentrations of intracellular calcium in single cells, contributing to a research program aimed at exploring the different components of intracellular signaling. This fundamental research work resulted in a Ph.D at the University Pierre and Marie Curie (Paris VI) in 1991. In parallel the technique was transferred to pharma industry research to investigate the mechanism CNS drugs such as riluzole.
Afterwards Jean-Christophe Delumeau joined the pharmaceutical industry working in international clinical research, in Basel (Hoffmann-La Roche, Novartis), Paris and Tokyo (Rhone-Poulenc Rorer). At Rhone-Poulenc Rorer, he conducted the multinational trial which confirmed the efficacy of an antiglutamate agent in amyotrophic lateral sclerosis, which trial resulted in the global approval of riluzole in this devastating disease. Afterwards, at Novartis, he continued to worke in the field of neurodegenerative diseases, especially Parkinson's disease.
In 2001, Jean-Christophe Delumeau was appointed by Bayer Yakuhin in Osaka, to support implementing a global reengineering program. From 2002 until 2009, he headed Bayer Yakuhin’s Pharmacovigilance department in charge of Drug Safety, Postmarketing Studies and Labeling. In October 2009, he was appointed as head of Pharmacovigilance for Asia-Pacific, based at Bayer Healthcare’s global development center in Beijing.
• How do companies ensure alignment of local, mandated RMPs with global RMPs?
• How can APAC countries implement globally mandated risk mitigation actions, especially when this may affect their business locally?
• Addressing key challenges on complying with local RMP’s
Since the 2015 International Society of Pharmacovigilance (ISoP)’s Prague meeting, the newly formed Special Interest Group is venturing into designing novel methods suitable for a large array of health care systems. Gain firsthand insights on the Post-Approval Vigilance Program (PAVP) concept. Hear from the relevant authorities on the latest progress and operational aspects of these customizable methods that are highly scalable, flexible and Risk-adjusted. Discover how this new programme addresses the diverse needs of non-ICH Asian countries and strategies on overcoming the reluctance of healthcare professionals in reporting suspected ADRs.
Merger and acquisitions are increasingly on the rise in the pharmaceutical and bio-technology industry. Done out of financial or business reasons, PV is often considered as afterthought and may be addressed late in negotiations on post-conclusions, at the risk of compliance or safety:
• How do you overcome operational challenges and manage the switch in ownership?
• Ensuring safety systems continue uninterrupted and that PV functions are carried out in a timely manner
• The role of the QPPV in ensuring a clear transition of responsibilities and the maintenance of activities
• How is compliance assured across multiple databases?
• Determining that all safety exchange agreements in place and valid