Training - ISoP - UMC Training

7th ISoP-UMC Training
Guangzhou, China
11-12 November 2019


Pharmacovigilance systems in China: Moving to the next step

Guangzhou-2019

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 and in December 2019 it was renewed for another 3-year term.

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 was conducted with expertise drawn from UMC & ISoP as well as local organizations and was designed to address the practical and theoretical aspects of pharmacovigilance from clinical trials to post-marketing surveillance.
The target audience included 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 covered 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 were delivered in English with simultaneous translation into Chinese.
Training was delivered through lectures, working groups and panel discussions.

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

Programme

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

Please click here to download the final programme – in Chinese (in PDF)

Please click here to download the brochure – in Chinese (in PDF)

Meeting Venue

DoubleTree by Hilton Guangzhou

DoubleTree by Hilton Guangzhou
广州希尔顿逸林酒店
No. 391 Dongfeng Road,
Guangzhou, Guangdong,
510030, China

Accommodation

You may book your room at the hotel venue DoubleTree by Hilton Guangzhou – at selected rates – with a booking link (available until 25 October), please contact administration@isoponline.org for the link.
Room Type (single) : King Bed Guestroom RMB 850 net incl 1BBF per night
Guaranteed credit card number&valid date
(Rooms subject to availability)

DoubleTree by Hilton Guangzhou
2002 Qiaocheng E. Road,Futian District,
No. 391 Dongfeng Road,
Guangzhou, Guangdong  

Tel +86 (0)20 2833 2888

The hotel venue is located in the Central Business District of Guangzhou, on the Dongfeng Road in the Yuexiu District, a 45-minute drive from Guangzhou Baiyun International (17.9 miles) and Shenzhen International Airport (1.5 hr) (48.2 miles).
It offers 301 guest rooms and suites with stunning views over the city or Yuexiu Park. The hotel offers also a swimming pool, spa, restaurants, parking on-site and free Wi-Fi access in public areas.

Check-in: 15.00
Check-out: 12.00

Guǎngzhōu (广州), China’s third-largest city – once called Canton – is the capital of Guangdong Province. Its location on the Pearl River and proximity to Hong Kong has made Guangzhou a strategic port and trading centre for centuries.
The city features modern architecture such as Zaha Hadid’s Guangzhou Opera House or the iconic Canton TV Tower skyscraper, with old temples, traditional eateries and parks.

Visa: To travel to Guangzhou most international visitors will need a visa.
For information about visa, please check with your embassy. Upon request, we can prepare an invitation letter to support participants visa application.