Training - ISoP - UMC Training

7th ISoP-UMC Training
Shenzhen, China
20-21 September 2019

Pharmacovigilance systems in China: Moving to the next step


The International Society of Pharmacovigilance (ISoP) and the Uppsala Monitoring Centre (UMC) have a common aim to explore the benefits and risks of medicinal products and to promote and enhance the safe and effective use of medicines. In January 2016, a revised Memorandum of Understanding (MOU) was signed by ISoP and UMC officials.

It is one of the primary objectives of ISoP and UMC to offer appropriate education and training in pharmacovigilance and to collaboratively intensify their activities in China. Since China formally joined ICH in June 2017, China pharmacovigilance regulations have significantly changed since 2018 moving forward with high standards and requirements for new PV systems and electronic data transmission (e.g. E2B R3). Those updated PV regulations cover PV activities from clinical to post- marketing surveillance. It is a great opportunity to seek views from global PV experts and learn from their experience about harmonization of safety reporting requirements and pharmacovigilance systems, to optimize the benefit risk ratio of medicinal products for Chinese patients and beyond.

This two day-course will be conducted with expertise drawn from UMC & ISoP as well as local organizations and is designed to address the practical and theoretical aspects of pharmacovigilance from clinical trials to post-marketing surveillance.
The target audience includes regulatory agencies, hospitals, universities as well as industry professionals in all areas of pharmacovigilance and those staff members in related functions, such as clinical trials, medical information, regulatory affairs, and audits.

The programme will cover topics such as:

  • ICH related topics such as E2B and its implementation as well as Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR) submissions
  • Terminologies used in pharmacovigilance: WHODrug and MedDRA
  • Experience sharing about good quality case reports in China
  • Safety evaluation and Risk management covering signal detection and serious organ toxicity
  • Introduction to new Chinese Regulations and their application in clinical trials and post-market surveillance
  • ISoP special interest groups with focus on Herbal and Traditional medicines and Medication Errors

The main lectures will be delivered in English with simultaneous translation into Chinese.
Training will be delivered through lectures, working groups and panel discussions.

This training is organized in the city of Shenzhen, Southeast China, in collaboration with the ISoP China chapter and The University of Hong Kong – Shenzhen Hospital.

Preliminary programme

Please click here to download the preliminary programme – in English (in PDF)

Meeting Venue

University of Hong Kong-Shenzhen Hospital

University of Hong Kong-Shenzhen Hospital
1 Haiyuan 1st Rd,
Futian Qu,
Shenzhen Shi,
Guangdong Sheng, China

Registration & Accommodation

Registration will open in April / May. Please save the date and register your interest!

More information regarding accommodation will be available later.