Webinar on Safety Cornerstone of Vaccine Clinical Trials: Building Vaccine Vigilance Systems and Meeting Regulatory Standards

Date: April 8,2025

Agenda:

15:00-15:05   Welcome Remarks & Introduction of participants, speakers and schedule

15:05-15:35   Establishment and development of PV system in Vaccine field

15:35-16:05   Regulatory requirements of PV in vaccine clinical trials

16:05-16:20   Online Interview

16:20-16:25   Q&A

16:25-16:30   Closing Remarks

Speakers introduction:

• Dr. Xiaoyao Conny MO

Conny Xiaoyao MO and her team provides PV technical services to biopharma industries, regulatory agencies, HCPs and their customers. She has total 25 years of  pharmacovigilance working experience including 18 years of  biopharma experiences in J&J/Pfizer/Merck/AZ China medical and global RnD.  Since 2017, Xiaoyao founded  PVing®, lead team to provide PV consulting and PV system quality audit to MAHs, sponsors and their vendors. She and team continued to research and develop safety database and PV data analysis tools.  They have solutions in signal detection used in real world data and different data sets. She accepted excellent leadership training from Harvard Business School. Prior to industry, she was a respiratory physician in Beijing Xuan Wu hospital, China.

Xiaoyao plays a leadership role for internal and external partnerships in PV enterprise.  From 2022, she was  assistant chief editor for Chinese Journal of Medicinal Guide. She is Pharmacovigilance committee member of China Society for  Drug Regulation since 2023, is ACC member of DIA China from 2020-2024, and a volunteer for DIA since 2010. She leads China Industry Pharmacovigilance (PV) working stream in RDPAC from 2004 to 2014.  She was invited by CFDA  as ICH expertise, Multidisciplinary group, China CFDA  ICH Study Group from 2009-2012. She reviewed Chinese version of clinical safety  related ICH guidelines in 2006-2007.  She was core teaching faculty of CCDRS postgraduate education program, collaborated among Peking university, University of Basel, Switzerland and University of California at San Francisco in 2008-2013 and key PV program for Training center of NMPA.

• Dr. Marc Ceuppens

Marc Ceuppens, MD, graduated as a medical doctor in 1991. He is an experienced vaccine and drug safety physician with a proven track record in various pharmaceutical companies for more than 25 years, including Janssen Pharmaceutica, Bristol-Myers Squibb and GlaxoSmithKline Vaccines. He most recently held the position of Therapeutic Area Safety Head for Vaccines, Infectious Diseases and Global Public Health products at Janssen, supporting multiple new product license applications and a variety of product safety, risk management and quality management activities. He joined P95 in June 2023 as PV advisor.

Original links: https://mp.weixin.qq.com/s/JHhLYYricvEkeg9hYEugQQ