Training - ISoP - UMC Training

The fifth pharmacovigilance training course jointly organized by ISoP and UMC is scheduled on 11-12 January 2018 in Shenyang (China)

The International Society of Pharmacovigilance (ISoP) and the Uppsala Monitoring Centre (UMC) have a common interest to promote scientific research and practice through the mutual exchange of information on adverse events and risks related to medicinal products.

In January 2014, a first Memorandum of Understanding (MOU) was signed by both parties, which establishes a strategic framework for a training collaboration. A primary focus was on Asia, a continent that accounts for 60% of the world’s population. It was considered that harmonisation of safety reporting requirements and pharmacovigilance systems would be of benefit for public health both on a global and a national level. After the Manila training in June 2014, the second Pharmacovigilance training course jointly organized by ISoP and UMC was scheduled for 12-14 January 2015 in Mysore, India.

In January 2016, a revised Memorandum of Understanding was signed by ISoP and UMC officials. The Latin America and Caribbean countries vary greatly in terms of level of pharmacovigilance. UMC and ISoP have identified a capacity building need in the Latin America region and a need to further strengthen pharmacovigilance systems. Therefore, the third pharmacovigilance training course jointly organized by ISoP and UMC took place in Lima, Peru from 7 to 9 September 2016 and the 4th ISoP-UMC Training in Panama from 4-6 September 2017.

Please click here for the latest version (2017-2019) of the Memorandum of Understanding (MOU).

5th ISoP-UMC Training
Shenyang, China
11-12 January 2018


Pharmacovigilance training:
from surveillance to inspections

BOOK YOUR PLACE NOW
ISoP-UMC Training course Shenyang

It is also 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. China has formally joined ICH in June 2017, it is great opportunity to seek view from global PV experts and learn from their experience on harmonization of safety reporting requirements and pharmacovigilance systems, to optimize the benefit risk ratio of medicinal products.

How does harmonization of active surveillance and signal detection evaluated by PV inspection lead to better safety governance?
This two day-course will be conducted with expertise from UMC & ISoP and local, and is designed to address the practical and theoretical aspects of pharmacovigilance.
Part of the training will also address the methodology of intensive safety monitoring using case studies.

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.
Training will be delivered through Lectures, working groups and panel discussions.

The programme will cover topics such as:

  • Individual case safety reports and Spontaneous Reporting Systems
  • Signal detection and management
  • Logical application of causality
  • PV inspection
  • Risk communication
  • Intensive safety monitoring programs

There was ample opportunity to exchange views and ideas in discussions following individual presentations, after the panel discussion at the end of the seminar and during coffee breaks.
The main lectures will be delivered in English with simultaneous translation.

This training is organized in the city of Shenyang, Northeast China, in collaboration with the ISoP China chapter and the International Food and Drug Policy and Law Research Center (IFDPL), Shenyang Pharmaceutical University.

 


Programme

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

Please Click here to download the preliminary programme – in Chinese (in PDF)


Meeting Venue

DoubleTree by Hilton

Hilton DoubleTree Shenyang
89 Fengyutan St, WuAi ShangQuan, Shenhe Qu, Shenyang Shi, Liaoning Sheng, China, 110011

DoubleTree Shenyang boasts 386 guest rooms, 24 suites, 24,000 sq. ft. of flexible meeting and banquet facilities on two levels, including one 6,969 sq. ft. pillarless Grand Ballroom. The hotel is the perfect venue for conducting business in northeastern China with meeting support services, 24-hour business center and a convenient and central Wu’ai Commercial Area location.
Hilton DoubleTree Shenyang is located only 30 minutes from Shenyang Taoxian International Airport (SHE).


 

Accommodation

We recommend the following hotel (hotel venue):

Hilton DoubleTree Shenyang
89 Fengyutan St, WuAi ShangQuan, Shenhe Qu, Shenyang Shi, Liaoning Sheng, China, 110011
Group rate of 500 CNY – 1 single room, breakfast & tax incl. (subject to availability), for reservation please contact directly Wei Wei Han (tel: +86 13610882243) quoting ‘ISoP meeting’.

Contact ISoP Administration for information about hotels in Shenyang.

Registration

The cost includes lunches, coffee breaks but does not include accommodation, dinner or travel.

Payment online / WorldPay

Please complete and return the registration form (here) to ISoP when paying online.
Amex, Visa and MasterCard accepted (6 euros will be added to cover bank charges to ISoP – this will be included in the total amount shown on payment page). When paying online for your registration, please refer to your e-mail from RBS WorldPay for transaction and receipt of payment.
If you encounter any issues when paying online, please contact administration@isoponline.org
The cost for 2-day seminar (11-12 January 2018):

ISoP Members from China, Private sector e.g. Pharma, CRO, Private hospitals:  310 Euros

+€6 card processing fee

Non-members from China, Private sector e.g. Pharma, CRO, Private hospitals:  410 Euros

(incl. one year’s membership until 31.12.18) +€6 card processing fee

ISoP Members from China, Public sector e.g. Academia, Authority, Public/military Hospitals: 155 Euros

+€6 card processing fee

Non-members from China, Public sector e.g. Academia, Authority, Public/military Hospitals: 240 Euros

(incl. one year’s membership until 31.12.18) +€6 card processing fee

Members of ISoP, Private sector e.g. Pharma, CRO, Private hospitals, HIC countries*: 410 Euros

+€6 card processing fee

Non-members of ISoP, Private sector e.g. Pharma, CRO, Private hospitals, HIC countries*: 650 Euros

(incl. one year’s membership until 31.12.18) +€6 card processing fee

(*) HIC (High Income) countries – outside China- include Hong Kong, Taiwan, Macao, Singapore, Brunei, Korea, Japan, Australia, New Zealand, Canada, USA, Israel, EU/AELE, Bahrain, Qatar, Saudi Arabia, Kuwait, Oman, UAE