1st ISoP-UMC Training
5-7 June 2014 | Manila, Philippines
Organised by: ISoP / UMC
Ensuring Safe Medicines: How harmonisation underpins international pharmacovigilance 5-7 June 2014 – Manila (Makati), Philippines.
Patient safety is one of the reasons that health care is constantly innovating and evolving, but one unexpected and harmful consequence of medicinal use is adverse reactions. Product safety to help patients get well, and to manage optimally, or ideally avoid, illness is a collective responsibility of Industry, Drug regulators, and Clinicians and other healthcare professionals. There are many methods for undertaking and using pharmacovigilance to protect patients.
The three day-course took place at the AIM Conference Center (Makati) and aimed to engage all interested pharmacovigilance professionals in a regulatory, industry, hospital, university or community setting.
The course faculty consists of Asian and International experts in pharmacovigilance, representing government, academia, and industry.
The programme included the following topics:
- Harmonization and adherence to international standards for pharmacovigilance reporting systems (WHO Programme for International Drug Monitoring, National Centre pharmacovigilance systems, and Industry pharmacovigilance monitoring systems)
- Individual Case Safety Reports (ICSRs), the need for structured and high quality data
- PV Methodologies (Industry reporting practice, Data Management, ICSR management tools, Effective data analysis and causality assessment protocols)
- Clinical and pharmacological assessment of adverse drug reactions
- Risk Management (Risk minimization strategies, Regulatory decision-making (panel discussion with drug regulators in the region)
- Communication and dissemination of pharmacovigilance information towards the public and other stakeholders. An analysis and discussion of the vaccine AEFI misinformation case study
The course included lectures, hands-on sessions and panel discussions. There was ample opportunity to exchange views and ideas both following individual presentations, after the panel discussions and during coffee breaks. Training Certificates were provided to those who complete the course.
A neutral forum for regional industry representatives, regulators and academia to share ideas, experience, concerns, and goals in an open and collaborative fashion. This training course had the following demographics:
Government / regulator-12
Summary of Demographics
Overall: Asia-69 China-1 Australia-1 Europe-3 | 72 participants
ABS-CBN Case room
123 Paseo de Roxas St
Campus of the Asian Institute of Management (AIM Makati) is one of the finest graduate schools in Asia. Its address at the heart of Makati Central Business District is only a 5-minute walk to major shopping centers.
Wifi is available at the AIM venue.
The Ninoy Aquino International Airport and the Manila Domestic Airport are approximately 8 kms away.
Taxis are widely available. Metro rail transits are also available in Metro Manila. Jeepneys and buses are inexpensive ways of getting around most places.
In June, the weather is between 25-33 degree Centigrade. Indoors in the caseroom can be chilly due to air conditioning (22 degree Centigrade or so). Dress code: business casual will do.
The school generally suggests no shorts, sandals while in the classrooms.
Participants may stay within the compound for their travel convenience considering the unpredictable traffic condition within the area. We recommend the following hotels. Rooms subject to availability:
AIM Conference Center Manila (ACCM) guestrooms
(Hotel accommodation adjacent to meeting venue)
J.V. del Rosario Bldg.,
Benavidez cor. Trasierra Sts
Legaspi Village, Makati City
Other recommended hotels in Makati City (walking distance from the venue) are:
The Copa Businessman’s Hotel
(published rate as of date: from PhP 2,452)
912, Pasay Road
One Greenbelt Hotel
914 Arnaiz Avenue (formerly Pasay Road),
City of Makati
(all rooms are subject to availability)
Requirements for entry into Philippines
Nationals from 151 countries may enter the Philippines without a visa and stay for a maximum of thirty (30) days, provided they are holders of a passport valid at least six (6) months beyond the period of stay in the Philippines, and present a return or outward bound ticket to their country of origin or to a next country of destination. More information about visas here and official website
We would be happy to prepare letter of invitation to participant if needed to secure a visa (Many Asian countries do not require visa to enter Philippines)
There are no medical requirements or health regulations for Manila/Makati.
Further information about the Philippines, please click here