This is the latest programme, which will be updated during the following weeks.
Monday, November 6th 2023
ROOM 1 - Kintamani Room
ROOM 2 - Denpasar Room
08:00 - 08.05
08:40 - 08.45
Introducing Pharmacovigilance: Background, Concepts, and Practices
Break & Discussion
08.45 - 08.50
08.50 - 09.10
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
Break & Discussion
10.00 - 10.30
Evaluation and Re-Evaluation of The Benefit vs Risk vs Uncertainties
10.30 - 11.00
Phytovigilance in the University Curriculum
End of Pre-Conference Course A
End of Pre-Conference Course C
*Lunch will not be provided
13.00 - 13.10
13.40 - 14.10
Quality Assurance and Quality Management in Pharmacovigilance in MAH Organisations (Including CAPA Management)
How Can PV Improve Public Health Programs?
14.40 - 15.00
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.