Understanding Pharmacovigilance Regulations in APAC Training Course

Pharmacovigilance Manager at Accestra Consulting

Mr. Raphael Tian is a seasoned pharmacovigilance Manager at Accestra Consulting, with extensive experience in top global pharmaceutical companies and a focus on the Chinese market. With hands-on experience in Adverse Event monitoring and reporting, Literature screening, Research Related Programs, Market Research and Patient Support Programs, PV agreements, Chinese GVP, and local regulations. Raphael is an experienced trainer in pharmacovigilance with a strong communication network in the local and global pharmaceutical industry in China. To learn more about Raphael or Accestra Consulting, please visit www.accestra.com.

Senior consultant at Accestra Consulting

Ms. Marylene Zhan is a senior consultant at Accestra Consulting with extensive experience in pharmacovigilance and regulatory affairs, with a Master's Degree from the Zhongnan University of Economics and Law. Marylene is a seasoned bilingual and bicultural consultant who specialises in China regulatory compliance and pharmacovigilance services (RA/PV). She has a wealth of knowledge on Chinese Pharmaceutical regulations and in-depth insight into dealing with Chinese market access requirements. Marylene has a rich experience in serving international pharma companies with market entry into China, providing support in the areas of adverse event monitoring and reporting, literature screening, PV agreements, Chinese GVP and local regulations, SOP & PSMF writing, and more. To learn more about Marylene or Accestra Consulting, visit www.accestra.com.

RA & PV Director at Accestra Consulting 

• Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China. 
• She is experienced in regulatory compliance of China market access & post-marketing maintenance of pharmaceutical products, providing insightful and customised solutions to international pharmaceutical companies and government institutions. 
• She leads the registration team to plan, develop and implement compliance strategies for top pharma clients and has a successful track record for obtaining market approval for drug products, APIs, Excipients, Packaging Materials, medical devices and other products.
• Ms. Ye has a strong communication network with Chinese authorities (e.g. NMPA and CDE) and industry experts in China. 
• To learn more about Helen or Accestra Consulting, please visit their website at www.accestra.com

Pharmacovigilance Manager at Pharma To Market

Ms. Priyanka Mangle is a Pharmacist with Master’s degree in pharmacy and post-graduate diploma in clinical research. She is an experienced Pharmacovigilance professional with hands-on experience in Adverse event monitoring & reporting, Literature & Regulatory Intelligence screening, Market Research & Patient support programs, Safety Data Exchange Agreements/PV agreements, SOP & PSMF writing, RMPs. She has actively participated in multiple audits and inspections including US-FDA audit, MHRA inspection and have also conducted vendor/business partner audits in past. She has a wide experience in conducting Pharmacovigilance training for a variety of regions including APAC, LATAM. She has in-depth knowledge of end-to-end PV processes along with global and regional regulations specific to Pharmacovigilance. She is currently based in Malaysia, working as Pharmacovigilance Manager at Pharma To Market, handling various pharmaceutical clients, working as QPPV and managing Pharmacovigilance activities in APAC regions.

Drug Safety Manager at Pharma To Market

Mr. Param Dayal is a qualified Microbiologist with Master’s degree in Microbiology and a certified MedDRA coder. For the last 15 years, Param has worked on a variety of pharmacovigilance projects with special focus on ICSR processing (Unsolicited, solicited, Literature, legal and Clinical trials cases). In his previous roles he worked for organisations supporting pharma clients with PSP program management, PV audits, HA inspections, data migration, SOP Management, process refinement, providing PV training and mentoring to new staff. He also has experience working as a QPPV and Local Safety Officer for Australia and New Zealand. He is currently based in Melbourne working as Drug Safety Manager for Pharma To Market, managing PV activities for NZ clients.