Lucky S. Slamet

Lucky S. Slamet got her degree in Pharmacy (Degree Dra, 1978) and professional Pharmacist (Degree Apotheker, 1979) from the University of Indonesia, Jakarta. She had her post graduate study at Queen’s University at Kingston Canada, majoring in Community Health and Pharmaco-Epidemiology studies (Degree MSc, 1991). She participated in several international trainings on regulatory aspects of medicinal products, including vaccines (for example, WHO Global Learning Opportunity, WHO Global Benchmarking Tools for Assessors, Drug Policy Issues in Developing Countries, Clinical Trial, Drug Evaluation, Adverse Drug Reaction Monitoring, WTO TRIPs and Dispute Settlement Mechanism). Recently, she got the certificate for WHO GBT assessor from the WHO Training Workshop for WHO GBT Assessor conducted by WHO HQ, Istanbul Turkey, June 2022

For more than 30 years, she worked as regulator of medicinal products, including vaccine at the Indonesian Food and Drug Authority (BPOM), with the last 2 positions as the Deputy Head for Therapeutic Products and Narcotics, Psychotropics, and Hazardous from 2001-2011 and the Head of BPOM from 2012-2013 (June) until her retirement. Since 2013 (July) up till now, she dedicates her professional expertise as the technical / independent consultant for BPOM and as core member of the Indonesian National Drug and Vaccine Evaluation Committee. Since 1998 up till now, she has been a lecturer for master program (majoring, National Drug Policy, Regulation and Ethics in Pharmaceutical) in the leading national Indonesian Universities (Faculty of Pharmacy University of Gajah Mada, Indonesia; Faculty of Pancasila, Indonesia).

She has lots of professional regulatory experiences in national, regional, and global level. Her major professional experiences at the national level among other, involvement in the Standardization and Regulation for Medicinal Products including Vaccine from 2001 till now  (for examples, Development of the Indonesian Pharmacopeiea, Guideline on Drug Registration, Guideline on Biosimilar, Informatorium on COVID-19 Medicines and Vaccine, Guidance for Evaluation of Antibacterial Drug, Good Regulatory Practice). She was member of the Indonesian National Research Board (2012-2014); and WHO STC at the National Development Planning Agency (Bappenas) to conduct the Indonesian Health Sector Review for the Formulation on Background Study for National Medium Term Development Plan 2020 – 2024, Theme Area 7 : Drug and Food Control, including Food Safety (2018-2019).

At the regional and global level, she was member of WHO ECBS / Expert Committee of Biological Standardization (2009 – 2016) and member of WHO ECSPP / Expert Committee on Specification for Pharmaceutical Preparations (2010 – 2013). She was chair of SEAR Member States Working Group of Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit (SSFFC) medical products (2010-2011); She  was appointed as a WHO Short Term Consultant (APW) on many regulatory activities, such as on the assessment of the implementation of ASEAN Harmonization on Pharmaceutical under WHO-ASEAN Project (2015-2016), on the Development of Action Plan for Capacity Building & Strengthening Regulatory Mechanism for Drug & Pharmaceutical Trade in SEA region (2015), on Regulations of Medicinal Product Advertisement including via Internet in Malaysia and Other Countries (2019), on strengthening the Marketing Authorization function of the NMRA Sri Lanka (2020), on formulation of a Human Resource Plan for the NMRA Sri Lanka (2021), on the revision of Circular 32/2018/TT-BYT of the Ministry of Health Viet Nam on Marketing Authorization of Drugs and Medicinal Ingredients (2021).

She participated as member of WHO NRA Assessment Team of the Vaccine and Medicine Regulatory System in some countries (The Philippines 2000; China 2014; Mexico 2015; Papua New Guinea 2016; Viet Nam 2018; Maldives 2022). She was a trainer/facilitator for WHO Vaccine Global Learning Opportunities (GLO) (2014-2017) on Clinical Data Evaluation (in Indonesia, Jordan, Viet Nam); on Clinical Trial Authorization (in Indonesia); and on Quality and non-Clinical Data Evaluation (in Vietnam, UEA, Tunisia, Turkey, Greece).

Up till now (2022), she is a visiting expert, in the Centre of Regulatory Excellence (CoRE) – NUS Medical School, Singapore for Training on Fundamental Pharmaceutical Regulation (2018-2022), and a board member of the Concept Foundation, Thailand/ Switzerland (2015-2022). She is now still involved with some regulatory activities under the USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program and the World Bank as Short Term Consultant.