This is the latest programme, which will be updated during the following weeks.

Monday, November 6th 2023


Pre-Conference Courses


ROOM 1 - Kintamani Room

ROOM 2 - Denpasar Room

08:00 - 12:00


Introduction to Pharmacovigilance

Jarir At Thobari


Pharmacovigilance of Herbals and Other Traditional Medicines

08:00 - 08.05


Opening Session


Opening Session

08:05 - 08.40


Phytovigilance & Regulatory Aspects: Current situation in Indonesia

08:40 - 08.45


Introducing Pharmacovigilance: Background, Concepts, and Practices

Break & Discussion

08.45 - 08.50

08.50 - 09.10

09.00 - 09.10


Optimising The Collection of Safety Information : A MAH and Regulator Perspective

Shabnam Sharan (Therapeutic Goods Administration)


Pharmacovigilance of Herbal & Traditional Medicines: International Organization and Functioning

09.10 - 09.15

09.15 - 09.20


Break & Discussion

09.20 - 09.40

Detecting and Managing Safety Signals in Pharmacovigilance

09.40 - 09.50


Phytovigilance: Challenges and Specificities, practical aspects

09.50 - 10.00

Coffe Break

Break & Discussion

10.00 - 10.30


Evaluation and Re-Evaluation of The Benefit vs Risk vs Uncertainties

Coffe Break

10.30 - 11.00


Phytovigilance in the University Curriculum

11.00 - 11.30


Effective safety communication and risk minimisation in diverse health care systems.

Sarah May (Therapeutic Goods Administration)


Phytovigilance in the University Curriculum

11.30 - 12.00


Interactive Q&A Session on effective safety communication and risk minimisation.


Presenters &



Interactive session with the Audience

End of Pre-Conference Course A

End of Pre-Conference Course C

*Lunch will not be provided

13.00 - 17.00


The New Indonesian GVP and its Annual Self-Inspection Requirement

Chairperson : Siti Asfijah Abdoella,

Jarir At Thobari


The Essential Role of Pharmacovigilance in Health Systems Management

13.00 - 13.10


Opening Session


Opening Session

13.10 - 13.40


Principles of Quality Systems Applicable in Pharmacovigilance


Introductory Presentation: What a Health Manager Needs to Know About PV and it’s Essential Role in The Health Systems?

13.40 - 14.10


Quality Assurance and Quality Management in Pharmacovigilance in MAH Organisations (Including CAPA Management)

Adrian Lim


How Can PV Improve Public Health Programs?

14.10 - 14.40


Preparing MAH Pharmacovigilance Organisations for Audits and Inspections.


Training Transdisciplinary Health Workers in PV: What are The Essentials for Creating a Responsive Team.

14.40 - 15.00

Coffee Break

Coffee Break

15.00 - 15.30


Most Critical and/or Common Deficiencies Affecting Pharmacovigilance Activities and TGA Experiences

Sarah May (Therapeutic Goods Administration)


The Role of Ethics, Decisions About Drugs and Navigating Trade-Offs Between Medicine Safety and Benefits: A Dilemma of Managers and Clinicians.

15.30 - 16.00


Application of PV in Health Technology Assessments and Cost-Effective Analysis: Deciding Medicines for a Hospital Formulary

16.00 - 16.10


BPOM’s Expectation for The New Indonesian GVP PV in The New Indonesian Health Bill

Togi J. Hutajulu (Badan POM Indonesia- NDFA)

16.10 - 17.00


Interactive Class Workshop: How Can Health Managers Address Drug Safety Disinformation and Improve Patient Literacy in Asian Region. This Session Calls for Case Studies and Groupwork

Brian Edwards & Panelist

17.00 - 17.10


Regulator’s Expectation Regarding Quality Management, Audits, Inspection Preparation and Behaviour During Inspections

Mandeep Rai, Sarah May, Togi J.Hutajulu

End of Pre-Conference Course B

End of Pre-Conference Course D

Course A: Introduction to Pharmacovigilance

Intended to any Health Carer Professional involved in pharmacovigilance-relevant activities (basically any HCP), Pre-Conference Course A will introduce the evolution of pharmacovigilance and its basic concepts over the past decades as well as its essential requirements and practices. Subsequent presentations will address more specifically: i) the detection of safety signals and their management, ii) the evaluation and periodic re-evaluation of the benefit versus risk and uncertainties of medicinal products, iii) Pharmacovigilance and risk minimisation planning, post-approval data generation, and how to adapt those methods to diverse health care systems. Those presentations will be followed by a practicum exercise involving the Audience combining benefit versus risk evaluation and design of a risk minimisation intervention.

Course B: The New Indonesian GVP and its annual self-inspection requirement

Pre-Conference Course B will include two parts. i) In the first part, presenters from Regulatory Authorities and Industry will provide essential knowledge on quality systems applicable to pharmacovigilance, quality assurance, internal audit, regulatory inspection preparation and conduct, most common or serious deficiencies identified during inspections, corrective actions and preventive actions (CAPA). ii) The second part will consist in a presentation explaining the expectations of the Indonesian FDA (BPOM) regarding the GVP released in 2022. This presentation will be followed by an interactive round table involving BPOM and Industry representatives on how to optimally implement the new requirements stated in the new Indonesian GVP, especially the requirement applicable to holders of pharmaceutical products license to audit annually their pharmacovigilance organisation in Indonesia. The Audience will be invited to ask questions and react, especially during the interacting round table.

Course C: Pharmacovigilance of herbals and other traditional medicines

The aim of this half-day course is to provide a basic understanding of the functioning concepts of Pharmacovigilance of Herbal and Traditional Medicines. The participants will learn about practices and limitations of phytovigilance, as well as its importance for the safety of herbal and traditional medicines. By the end of the course, one should be able to: – be familiar with pharmacovigilance of Herbal Medicines in terms of organization, missions and functioning – gain an understanding of the importance of Herbal & Traditional medicines regulatory aspect – understand communication in phytovigilance – Learn about how Morocco has introduced phytovigilance in the University Curriculum – There will be plenty of time for Q&A and we look forward to lively discussions.

Course D: The essential role of pharmacovigilance in Health Systems Management

Health Systems as we know is very complex and the manager of the system has to know information and possess competence. It does not rest on one person but a team of transdisciplinary experts. Where does and how does pharmacovigilance play a critical role in managing this complex health system? At the end of this pre-conference education-workshop, the manager is expected to know and apply PV in their work, with the goal of improving patient and societal health outcomes. The course will take a systems approach in the design. In the governance of health service, we look at how PV is helping public health programs both in the communicable and in the non-communicable disease sector and call for improvements. But health services are diverse and hence we need to ensure that there is a responsive health transdisciplinary human resources able to function as a team anchored with common drug safety principles. Necessarily, a manager will then have to appreciate drug benefits and risks and how will this trade off in decision making happen – it will require a scientific approach like health technology assessments and an ethical framework. Lastly, as disinformation and misinformation is on the rise, the health manager will need to know how to apply PV to correct such harm such as creating literacy interventions.