Training - ISoP - UMC Training

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


Pharmacovigilance systems in China: Moving to the next step

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Ecuador-2018

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.

Programme

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

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

Please click here to download the brochure – in Chinese (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

Accommodation

You may book your room at the selected hotel St Helen Shenzhen Bauhinia – Rooms subject to availability –
Please e-mail directly the reservation department at : hotel@st-helen.com.cn with the following information:
Corporate from : HKUSZH
Guest Name
Check-in date
Check-out date
mobile phone number
Room Type : Executive Standard King/Twin RMB 638 incl 1BBF (27 sqrm),Executive Deluxe King/Twin RMB 878 incl 1BBF(40 sqrm)
Guaranteed credit card number&valid date
Cancellation policy : 3 days before arrival check-in date.

St Helen Shenzhen Bauhinia
2002 Qiaocheng E. Road,Futian District,
Shenzhen 518040 Guangdong Province.P.R.China   

Tel +86 (0) 755 8282 9966
Hotel Brochure, click here

Situated within walking distance of Qiaocheng East Station and about 10 minutes walking distance from the training venue, St Helen Shenzhen Bauhinia hotel is one of the newest and modern hotels in Shenzhen with 4-star rooms, free Wi-Fi, an outdoor pool and spa.

Shenzhen Bao’an International Airport (22 km) – daily flights to all major destinations in China – is a 50-minute drive from the hotel.
Hong Kong International Airport is situated at 26 km.

Check-in: 14.00
Check-out: 12.00

Shenzhen
Chinese Name: 深圳市

Shenzhen, major city in Guangdong Province, in southeastern China, is a modern metropolis that links Hong Kong to China’s mainland.
To travel to Shenzhen you will need a visa. For information about visa, please check with your embassy.

Registration

Already a Member of ISoP?

Current members of ISoP are eligible for a “member” rate. Please choose the appropriate option below when logged in to your account.

Full Registration

High Income Countries*

(Conditions apply – see below)

€450.00 + 12 Euros Card fee.
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Full Registration

China

(Private Sector e.g. Pharma, CRO, Private Hospitals)

€350.00 + 12 Euros Card fee.
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Full Registration

China

(Public Sector e.g. Academia, Authority, Public/Military Hospitals)

€200.00 + 12 Euros Card fee.
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Not a Member of ISoP?

Non member registrations for the 7th ISoP-UMC Training Course include complimentary ISoP Membership.
Please choose the appropriate option below to pay online with your credit card.

If you have any questions or wish to pay via Bank Transfer please contact ISoP Administration

Fees include lunch with drinks and coffee breaks but do not include accommodation, dinner or travel.

Full Registration

High Income Countries*

(Conditions apply – see below)
 

€650.00 + 12 Euros Card fee.

(Includes complimentary ISoP Membership)
REGISTER NOW

Full Registration

China

(Private Sector e.g. Pharma, CRO, Private Hospitals)

€450.00 + 12 Euros Card fee.

(Includes complimentary ISoP Membership)
REGISTER NOW

Full Registration

China

(Public Sector e.g. Academia, Authority, Public/Military Hospitals)

€300.00 + 12 Euros Card fee.

(Includes complimentary ISoP Membership)
REGISTER NOW

(*)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