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Upcoming Workshop



APEC RHSC Centre of Excellence Pilot Workshop
Biotherapeutics

29 - 30 October 2018 Lead on 3, Level 3 Duke-NUS Medical School
2016 APEC Biotherapeutics Centers of Excellence Pilot Training
Day 1
time Topic Speaker / Organisation
8.30am Registration
9:00am Welcome Professor John CW Lim
Executive Director
Centre of Regulatory Excellence
Duke-NUS Medical School
9:10am
  • Workshop Briefing
      • Objectives and conduct of workshop
      • Define Biotherapeutics and Biosimilars
Asst Prof James Leong
Head
Pharmaceutical Regulatory Science Programme
Centre of Regulatory Excellence
Duke-NUS Medical School
Session 1 – Regulatory Requirements for Biotherapeutics
9.30am
  • Key learnings from existing guidelines governing the regulation of biotherapeutics
      • Overview of the major global guidelines
      • Key principles in regulation of biotherapeutics
      • Highlight some best practices within the major regulatory authorities
10.00am Break and Photograph Taking
Session 2 – Quality Requirements for Biotherapeutics
10.30am
  • Quality evaluation for biotherapeutics
      • Overview of CMC requirements and scope for biotherapeutics
      • Key components in characterisation and comparability of biotherapeutics
11.10am Pharmacopeia and standards setting
11.30am
  • Case example and team-based exercise
      • CMC assessment of biotherapeutics
12.30pm Lunch
Session 3 – Non-Clinical and Clinical Considerations for Biotherapeutics
1.30pm
  • Non-clinical studies for biotherapeutics
      • Overview of non-clinical considerations when evaluating biotherapeutics
      • Key non-clinical aspect: Pharmacokinetics/ pharmacodynamics
2.00pm
  • Clinical studies of biotherapeutics
      • Overview of clinical considerations when evaluating biotherapeutics
      • Overview of clinical study design
      • Key clinical aspect: Immunogenicity
2.45pm Case example and team-based exercise
3.30pm Break
4.00pm
  • Panel Discussion
    • - Current landscape for biotherapeutics in the region
    • - Opportunities for better regulation of biotherapeutics
      • Policies, frameworks and guidelines
      • Submission and review processes
      • Product life cycle management
5.15pm Conclusion for Day 1
5.30pm End
2016 APEC Biotherapeutics Centers of Excellence Pilot Training
Day 2
time Topic Speaker / Organisation
8.30am Registration
Session 4 – Regulatory Requirements for Biosimilars
9:00am
  • Key learnings from existing guidelines governing the regulation of biosimilars
    • - Overview of the major global guidelines
    • - Key principles in regulation of biosimilars
    • - Highlight some best practices within the major regulatory authorities
      • EMA’s product specific biosimilar guidelines
Session 5 – Quality Requirements for Biosimilars
9.45am
  • Quality evaluation for biosimilars
    • - Key components in characterisation and comparability of biosimilars – ICH Q5E
      • Biosimilar product development
      • Reference medicinal product
      • Assessment of similarities and differences in biosimilar product and RMP
    • - Shift in QTPP during product lifecycle
10.30am Break
11.00am
  • Case example and team-based exercise
      • CMC assessment of biosimilars
12.30pm Lunch
Session 6 – Clinical Considerations for Biosimilars
1.30pm
  • Clinical safety studies of biosimilars
    • - Key clinical considerations when evaluating biosimilars
    • - Clinical comparability of biosimilars
      • Study designs and approaches – Stepwise and Totality-of-evidence
      • Justification of endpoints
      • Requirements for interchangeability, substitution and switching
Session 7 – Post Market Activities for Biotherapeutics and Biosimilars
2.15pm
  • Pharmacovigilance for strengthening approaches to regulation
    • - Monitoring of safety and efficacy comparability
    • - Adequacy and utility of immunogenicity data
    • - Managing signals and trends from databases of biosimilars and reference products
    • - Advertising and labelling requirements
3.00pm Break
3.30pm
  • Post market risk management and communication
    • - Components of post market risk management
    • - Reviewing risk management strategies
    • - Effective risk communication to stakeholders
4.10pm
  • Group activity
    • - Brief RMP review to ensure that PV requirements are met
4.30pm
  • Panel Discussion
    • - Current landscape for biosimilars in the region
      • Accessibility – Does biosimilar reduce cost and increase accessibility to patients?
    • - Opportunities for better regulation of biotherapeutics and biosimilars
      • Policies, frameworks and guidelines
      • Submission and review processes
      • NRA competency
      • Product life cycle management
      • Managing safety with post market activities
3.00pm Conclusion of Workshop
5.30pm End