Regulatory Strategy for ASEAN
- Insights from local regulatory experts
- Understand local dossier requirements, pathways and timelines
- Avoid common regulatory pitfalls
- Officially certified according to ISO 9001 and ISO 21001
Series (completed)
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space, and technical support including a pre-meeting. The webcast sessions will be recorded and will be available in the Learning Space for 90 days.
Buchungsdetails
Series (completed)
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space, and technical support including a pre-meeting. The webcast sessions will be recorded and will be available in the Learning Space for 90 days.
This webcast series provides a practical overview of regulatory approval pathways, dossier requirements and market entry considerations for pharmaceutical products across key ASEAN markets. You will learn how to prioritise target countries, plan efficient submission strategies and address important local requirements, timelines and common pitfalls.
Speaker
Jack (Lung) Wong
CEO of RNAscence and Founder of Asia Regulatory Professsionals Association (ARPA), SINGAPORE
Jack Wong has over 26 years of experience in the Pharma and MedTech sectors. He is the founder of the Asia…
Your speaker
Jack (Lung) Wong
CEO of RNAscence and Founder of Asia Regulatory Professsionals Association (ARPA), SINGAPORE
Jack Wong has over 26 years of experience in the Pharma and MedTech sectors. He is the founder of the Asia Regulatory Professionals Association (ARPA), which has a membership of more than 7,000 professionals. Additionally, he is the author of the Medical Regulatory Affairs Handbook (3rd edition).
He holds adjunct professor and lecturer positions at the Chinese University of Hong Kong, Hong Kong University, the National University of Singapore, and Tohoku University in Japan. He is also the CEO of RNAscence, a biotech start-up spin-off from Nanyang Technological University and the National Skin Centre in Singapore.
Christine Marie Olores
Regulatory Affairs Hub Coordinator for the Asia-Pacific (APAC) Region
Ms. Christine Marie Olores is a Regulatory Affairs professional with over a decade of experience in pharmaceutical and cosmetic…
Your speaker
Christine Marie Olores
Regulatory Affairs Hub Coordinator for the Asia-Pacific (APAC) Region
Ms. Christine Marie Olores is a Regulatory Affairs professional with over a decade of experience in pharmaceutical and cosmetic regulatory operations across the Asia-Pacific region and beyond. Most recently, as Regulatory Affairs Hub Coordinator (APAC) at PharmaLex where she led lifecycle maintenance for a portfolio of over 40 outsourced product licenses, coordinating regulatory submissions, variations, renewals, and safety reporting across ASEAN countries, India, South Korea, Australia, and other APAC markets, while mentoring a team of over 10 colleagues.
Previously, as International Regulatory Affairs Coordinator at F.C.P. Company Ltd. in Thailand, Ms. Olores managed regulatory submissions in ACTD/CTD formats for 25+ products across 14+ international markets, spanning Asia, East Africa, and the Middle East - overseeing everything from technical dossier compilation to packaging compliance and deficiency responses.
Ms. Olores´ career began in pharmaceutical research and development and regulatory compliance roles in the Philippines, including positions as a Company Pharmacist and R&D Pharmacist, where they gained hands-on experience in product formulation, stability testing, and cosmetic/drug registration with the Philippine FDA. She is also a registered Pharmacist in the Philippines.
With deep expertise in international regulatory frameworks, cross-functional coordination, and regulatory documentation systems (Veeva Vault, SAP GUI, ZOLA, QUEST), Ms. Olores brings a strong track record of managing complex, multi-country regulatory portfolios.
What to Expect
- Overview of key ASEAN markets: Singapore, Malaysia, Indonesia, Thailand, Vietnam, the Philippines, Cambodia, Myanmar, Laos and Brunei
- Strategic planning of market prioritisation, submission sequencing and dossier preparation
- Practical guidance on approval pathways, ACTD/CTD requirements, GMP, labelling and pharmacovigilance
- Key considerations for timelines, local representation, import licences, registration samples and common deficiencies
- Comparative assessment of regulatory complexity, market attractiveness and practical entry options
Who Should Attend
The webcast series is designed for professionals from regulatory affairs, international registration, market access, global launch planning and related functions in pharmaceutical companies who are involved in preparing, coordinating or managing submissions in Southeast Asia.
Prior knowledge of EU regulatory frameworks is recommended.
Objective of the Event
This webcast series provides a practical overview of regulatory approval pathways, dossier requirements and market entry considerations for pharmaceutical products across key ASEAN markets. Participants will learn how to prioritise target countries, plan efficient submission strategies and understand important local requirements.
Can't attend live? All webcasts are available on demand for 90 days in the password-protected customer portal.
Your Benefit
You will gain:
- a compact overview of the main pharmaceutical regulatory frameworks in ASEAN
- practical guidance for submission planning and market prioritisation
- insights into country-specific requirements, timelines and common pitfalls
Programme
Dates: 19 + 20 + 24 + 25 November 2026, 09:00 - 11:00
Day 1
- Speaker introductions and learning objectives
Jack (Lung) Wong
- Overview of the ASEAN pharmaceutical markets
- How to prioritise markets and sequence submissions
- Strategic considerations for dossier planning and market entry
- Timeline planning and critical path considerations
- Selecting local partners and planning local market access
- ASEAN Joint Assessment Procedure: status and relevance
- Q&A
Jack (Lung) Wong
- Pathway selection: Full, Abridged and Verification Route
- Verification Route: requirements, process and timeline
- Dossier requirements: CTD format, local administrative documents and product information requirements
- GMP: PIC/S membership, EU GMP recognition and inspections
- Labelling requirements
- E-submission via PRISM, pharmacovigilance and variations
- Common pitfalls and rejection reasons
- Q&A
19.11.2026 - Singapore
Welcome and Introduction
Welcome and Introduction
- Speaker introductions and learning objectives
Introduction to the ASEAN Markets and Regulatory Strategy
Introduction to the ASEAN Markets and Regulatory Strategy
Jack (Lung) Wong
- Overview of the ASEAN pharmaceutical markets
- How to prioritise markets and sequence submissions
- Strategic considerations for dossier planning and market entry
- Timeline planning and critical path considerations
- Selecting local partners and planning local market access
- ASEAN Joint Assessment Procedure: status and relevance
- Q&A
Short break
Singapore (HSA)
Singapore (HSA)
Jack (Lung) Wong
- Pathway selection: Full, Abridged and Verification Route
- Verification Route: requirements, process and timeline
- Dossier requirements: CTD format, local administrative documents and product information requirements
- GMP: PIC/S membership, EU GMP recognition and inspections
- Labelling requirements
- E-submission via PRISM, pharmacovigilance and variations
- Common pitfalls and rejection reasons
- Q&A
Day 2
Jack (Lung) Wong
- Pathway selection: Full, Abbreviated and Verification
- Dossier requirements: ACTD format, local annexes and substance documentation requirements
- GMP: PIC/S membership, EU GMP recognition and audits
- Halal certification: relevance, JAKIM requirements and planning considerations
- Labelling in Bahasa Malaysia, pharmacovigilance and variations
- Timelines and common deficiencies
- Q&A
Jack (Lung) Wong
- Registration procedures and product categories
- Dossier requirements: ACTD plus local documents
- Local regulatory requirements for manufacture, import and market access
- GMP: PIC/S status, CPOB inspections and EU GMP recognition
- Stability studies in zone IVb and other product-specific expectations
- Document legalisation requirements and current practice
- Labelling, local representation, pharmacovigilance and variations
- Timelines and deficiency letters
- Q&A
20.11.2026 - Malaysia and Indonesia
Malaysia (NPRA)
Malaysia (NPRA)
Jack (Lung) Wong
- Pathway selection: Full, Abbreviated and Verification
- Dossier requirements: ACTD format, local annexes and substance documentation requirements
- GMP: PIC/S membership, EU GMP recognition and audits
- Halal certification: relevance, JAKIM requirements and planning considerations
- Labelling in Bahasa Malaysia, pharmacovigilance and variations
- Timelines and common deficiencies
- Q&A
Short break
Indonesia (BPOM)
Indonesia (BPOM)
Jack (Lung) Wong
- Registration procedures and product categories
- Dossier requirements: ACTD plus local documents
- Local regulatory requirements for manufacture, import and market access
- GMP: PIC/S status, CPOB inspections and EU GMP recognition
- Stability studies in zone IVb and other product-specific expectations
- Document legalisation requirements and current practice
- Labelling, local representation, pharmacovigilance and variations
- Timelines and deficiency letters
- Q&A
Day 3
- Speaker introductions and learning objectives
Christine Marie Olores
- Registration procedures and product classification
- Dossier requirements: ACTD format, local specifics
- GMP inspections and EU GMP recognition
- Stability studies in zone IVb and storage conditions
- Labelling (Thai), local representation,
- Pharmacovigilance, variations and timelines
- Registration Samples and requirements (Import License)
- Thailand as a strategic gateway for Cambodia, Myanmar and Laos
- Market access and registration considerations for Cambodia, Myanmar, Laos and Brunei
- Q&A
Christine Marie Olores
- Registration pathways for initial applications, renewals and product maintenance
- Regulatory strategy for managing changing local requirements in practice
- Dossier requirements: ACTD format and local specifics
- GMP: EU GMP vs. WHO GMP recognition, inspections
- Bioequivalence, labelling in Vietnamese
- Stability studies and storage conditions
- Local representation, pharmacovigilance and variations
- Registration samples and import licence requirements
- Timelines
- Q&A
24.11.2027 - Thailand and Selected Emerging ASEAN Markets, Vietnam
Welcome and Introduction
Welcome and Introduction
- Speaker introductions and learning objectives
Thailand (Thai FDA) and Selected Emerging ASEAN Markets
Thailand (Thai FDA) and Selected Emerging ASEAN Markets
Christine Marie Olores
- Registration procedures and product classification
- Dossier requirements: ACTD format, local specifics
- GMP inspections and EU GMP recognition
- Stability studies in zone IVb and storage conditions
- Labelling (Thai), local representation,
- Pharmacovigilance, variations and timelines
- Registration Samples and requirements (Import License)
- Thailand as a strategic gateway for Cambodia, Myanmar and Laos
- Market access and registration considerations for Cambodia, Myanmar, Laos and Brunei
- Q&A
Short break
Vietnam (DAV)
Vietnam (DAV)
Christine Marie Olores
- Registration pathways for initial applications, renewals and product maintenance
- Regulatory strategy for managing changing local requirements in practice
- Dossier requirements: ACTD format and local specifics
- GMP: EU GMP vs. WHO GMP recognition, inspections
- Bioequivalence, labelling in Vietnamese
- Stability studies and storage conditions
- Local representation, pharmacovigilance and variations
- Registration samples and import licence requirements
- Timelines
- Q&A
Day 4
Christine Marie Olores
- CPR process, dossier requirements and GMP considerations
- Reliance on reference agencies
- Labelling, pharmacovigilance and variations
- Stability studies and Storage Condition
- Registration Samples and requirements (Import License)
- Timelines
- Q&A
- Summary of key regulatory considerations across the featured markets
- Comparative assessment of timelines, complexity and market attractiveness
- Comparative assessment of market attractiveness and practical entry considerations
- Q&A
25.11.2026 - Philippines
Philippines (FDA Philippines)
Philippines (FDA Philippines)
Christine Marie Olores
- CPR process, dossier requirements and GMP considerations
- Reliance on reference agencies
- Labelling, pharmacovigilance and variations
- Stability studies and Storage Condition
- Registration Samples and requirements (Import License)
- Timelines
- Q&A
Short brake
ASEAN Market Comparison and Final Discussion
ASEAN Market Comparison and Final Discussion
- Summary of key regulatory considerations across the featured markets
- Comparative assessment of timelines, complexity and market attractiveness
- Comparative assessment of market attractiveness and practical entry considerations
- Q&A
Downloads
Request the documents using our form.
Brochure
List of Abbreviations: Drug Regulatory Affairs / CMC
More information
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Your Contact Person
We are happy to advise you personally and individually.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de