Training - ISoP Mid Year Training Course
ISoP Mid Year
25-27 April 2016
PV Management: Devising and organizing effective operations for ensuring safe and appropriate use of medicinal products.
Mid-year training course – Makati-Manila (Philippines)
This three day-course was conducted to leverage the Pharmacovigilance expertise of ISoP and designed for interdisciplinary groups to learn and work together in order to enhance patient safety when medicines are used.
The course started with one day session and an interactive workshop devoted to the understanding of basic organizational management, and resolving some of the usually not discussed aspects of managing people within therapeutic committees, PV centers, regulators, industry units handling PV concerns, funding, communicating with superiors and funders of PV work.
On day 2, there was a half-day session on the statistical and epidemiological tools that assist the PV practitioners to understand and make decisions on risk-benefit judgment. Various perspectives from regulators, industry, clinicians, and committee decision makers were also studied. Then, the recognition of the medical manifestations of Adverse Drug Events was studied in the afternoon, taking into account the perspectives of specialists who sees these drug induced conditions by way of referrals, and how to manage these conditions, how to communicate with patients. Patients were invited in a guided focus group discussion to obtain a reality of how they cope with ADEs and how they can contribute to global reporting.
The last day was devoted to the study of using laboratory to support ADR investigations, and how hospital laboratory results as gleamed from patient charts can be used for research and early identification of life-threatening ADRs. There was also a session on new trends in education and training of PV in health professional schools.
At the end of the course, the participants were expected to appreciate the complexities of pharmacovigilance and be able to better use appropriate tools to advance better detection, monitoring, reporting and prevention. Risk management was another important course content that will align regulators and industry to promote product safety. Hands- on interactive tasks, panel discussions and lectures were the main instructional approaches.
This course was aimed to engage all interested pharmacovigilance professionals in a regulatory, industry, hospital, university or community setting.
The programme covered topics such as:
- Introduction to Management and Management in everyday practice (Re Chapters of the PV curriculum are chapters 11, 12, and 13)
- The epidemiology of PV, Risk assessment and ‘Benefit-to-harm assessment’ (Relevant chapters of the PV curriculum are: Chapters 7, 8, and 15)
- Clinical Science of PV (Re Chapters of the PV curriculum are chapters 2, and 3)
- Laboratory science of PV (Re Chapter of the PV curriculum is chapter 4)
- Education and training of PV (Re Chapter of the PV curriculum is chapter 12)
- Risk management (Re Chapter of the PV curriculum is chapter 11)
The course faculty consisted of Asian and International experts in pharmacovigilance, representing government, academia, and industry.
Training certificates of attendance were provided to those who complete the course.
Please click here to download PDF (Final programme).
AIM Conference Center Manila
JV del Rosario bldg.
Benavidez cor Trasierra st.
It’s 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.
In April, the weather is between 29-33 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.
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.
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
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
912, Pasay Road ,
Astoria Greenbelt (One Greenbelt hotel)
914 Arnaiz Avenue (formerly Pasay Road),
City of Makati
(all rooms are subject to availability)
The Philippines is a Southeast Asian country in the Western Pacific. The Philippines archipelago comprises 7,107 colourful islands. The local currency in the Philippines is the Philippine peso.
Located in the heart of Metro Manila, Makati is the central, vibrant and cosmopolitan business city of the country with restaurants, hotels and the best shopping malls.
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 at: http://www.dfa.gov.ph/
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 Manila at:
Need more information?
If you would like more details about this course please contact ISoP Administration