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P40077 Pharma Regulatory Affairs
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Pharma Regulatory Affairs

28 – 29 June 2018, Mandarin Orchard Hotel, Singapore

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Key Learning Outcomes

  • Current priorities in regulatory compliance across the Globe and Asian Markets
  • Understand the approval, submission, registrations processes and differences in requirements for R&D products and generics
  • Understanding markets and exclusivity – what is being regulated
  • Regulations and procedures for biosimilars and generics
  • Discuss harmonisation initiatives including ASEAN opportunities
  • Discover general country specific and regional requirements
  • Regulatory strategies for OTC products
  • Pharmacovigilance and individual country requirements
  • Tackling supply chain, packaging and labelling regulations
  • Emerging regulatory issues in the digitalisation of Pharma

Dedicated Case Studies and Exercises on:

  • ASEAN generic launch
  • Asian OTC products
  • European /US opportunity

Who Should Attend

Personnel from

  • Analytical Research and Development
  • Clinical Development
  • Quality Assurance
  • New Business Development Departments
  • Regulations and Compliance
  • Market Access, Market Development and Marketing professionals


What past participants have said about our Pharma Courses:

“Exercises were useful and trainer is knowledgeable”
– Noor Aida Binti Jaafar, Head of Marketing & Specialty Care, CCM Pharmaceutical

“Case Studies and the workshop activities really helped a lot and more practical”
– Praveen Kumar, Senior Manager, Pharmaniaga

“Informative & insightful. Had a chance to network and share discussion / cross learn from participants”
– Chng Kien Peng, Executive Director, Xepa-Soul Pattinson (S) Pte Ltd

“The course is very relevant to my job. The case studies and the workshop activities really helped a lot and were practical.
– Avadhanula Yagna Praveen Kumar, Senior Manager Intellectual Property, Pharmaniaga BHD

“Very informative. It covers all scopes under the topics”
– Norliza Binti Abdullah Zawawi, Legal Assistant Manager, Pharmaniaga Berhad


Peter Wittner

Yeeju Chen

Managing Consultant, PharmEng, Singapore

Jonathan Kok

Partner, RHTLaw Taylor Wessing, Singapore


Day One

The background – why does regulation exist?

Why is registration necessary?

  • History of regulatory requirements
  • The Pharmacopoeia
  • How Thalidomide changed everything

History – overview of how the regulations developed

  • The main regulatory bodies – who, what and how
  • UK’s CSM
  • US FDA
  • Europe – the EMA
  • Moves towards harmonisation – ICH

Overview of differences between requirements for R&D products and generics

  • Hatch Waxman (US)
  • European directives
    • EU definition of a generic
  • Biosimilars – simplified, but still complex

Understanding markets and exclusivity – what is being regulated
Impact of patents and Data Exclusivity

  • Europe – quality, safety and efficacy
  • Europe – launching before patent expiry
  • US – challenging patents by filing an ANDA
  • US – what is Paragraph IV?

What is data exclusivity?

ASEAN considerations

  • How do the national regulations compare?

Generics and Biosimilars
Understanding biosimilars regulations

  • Why the interest?
    • Hybrid products – not originators, but not really generics
    • Markets and products
    • Success stories
  • History of biosimilar regulatory procedures
    • Europe – path finders
    • USA – slow starters
    • ASEAN countries
    • India and China

Regulatory requirements for generics

  • Relevant legislation – US, Europe and key Asian markets in focus
  • Impact of regulatory processes on the market

Legislation –a bit more detail

  • Hatch Waxman (US)
    • Why was it introduced?
    • Advantages for originators
    • Advantages for generics
  • European directives
    • Removing the barriers
    • Generic definition
    • European reference product

European Regulatory mechanisms

  •  Centralised, DCP, MRP systems
    • Who reviews the dossier?
      • The different European bodies


  • What is it?
  • Which reference products can be used
  • CTD European style

Moves towards international harmonisation

  • ICH purpose and aims
  • From paper to CDs and on-line filing – eCTD
    • The five modules:
      • Administrative information and prescribing information
      • Common technical document summaries
      • Quality
      • Nonclinical study reports
      • Clinical study reports

Brand to OTC switch

  • Why switch?
    • Advantages
    • Disadvantages
  • Rules and regulations – overview
    • What can be switched?
    • Are the rules uniform everywhere?
  • Individual ASEAN country requirements
    • Singapore, Malaysia, Indonesia and Philippines

Review of Day 1 topics and questions

Day Two

Focus on ASEAN – part 1

  • Current priorities in regulatory compliance in APAC with focus on ASEAN countries
  • Key areas of noncompliance, and frameworks to manage them
  • Regulatory updates – harmonization, new policy, clarity and speed in licensing, submission and approval in the region
  • Recent Trend of Pharmaceutical Regulations – Approvals, Submissions, Registrations, Pharmacovigilance, New Medicine Development, patient labelling
  • eCTD and RPS – APAC Progress in eSubmissions
  • Accelerating Drug Approval in Asia – Overview of Time-Frames, Drug Registration Procedures, Opportunities and Challenges
  • Regulatory strategies for OTC products – Registration, License, Compliance, Safety and Risk Control
  • Accelerating Drug Approval in Asia: Time-Frames and Procedures
  • Whats next?


Focus on ASEAN – part 2

After registration ASEAN

  • Pharmacovigilance – monitoring safety
  • Individual country requirements


  • Definitions and Types
    • What is needed?

Pharmaceutical competition law

  • What are the issues?
  • ASEAN focus

Guest Speaker: Yeeju Chen, Managing Consultant, PharmEng

Pharma 4.0 – emerging regulatory issues in the digitalisation of Pharma

  • Data protection and privacy
  • Digital Health Technology (DHT) – what does it mean?
  • Other areas?

Guest Speaker: Jonathan Kok, Partner, RHTLaw Taylor Wessing

Supply Chain, Packaging and labelling
Supply Chain regulations

  • Counterfeit drugs
    • Overview of the problem – how big is it?
    • Can you spot the fakes?
  • Patent infringement – not the same as counterfeiting
  • EUFMD – Falsified Medicines Directive
    • History
    • Aims
  • USDSCA – Drug Supply Chain Security Act
    • History
    • Aims
    • Deadlines
  • Solutions
    • Meet EPCIS (Electronic Product Code Information Services)
  • Asia – a fragmented approach

Measures to avoid counterfeiting

  • Serialisation
  • 2d barcodes

Packaging text regulations

  • What should the text show?
    • Prescription packs
    • OTC packs
  • What should it not show?

Leaflet texts

  • What do they need to show?
  • Physician’s leaflet and patient leaflets – the same but different

How ASEAN countries view the issue

Pharma 4.0 – emerging regulatory issues in the digitalisation of Pharma

  • Data protection and privacy
  • Digital Health Technology (DHT) – what does it mean?
  • Other areas?

Review of Day 2 topics and opportunity for questions


when & where

28 - 29 Jun 2018

Mandarin Orchard Singapore, by Meritus
333 Orchard Road, Singapore 238867
Tel: +65 6831 6062 | Fax: +65 6737 3130
Mobile No.: +65 8298 9442
Contact Person: Tan Ai Li

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