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P40094 Biosimilars – Regulation, Drug Development & Commercialisation
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Biosimilars – Regulation, Drug Development & Commercialisation

25 – 26 July 2019 | Mandarin Orchard Hotel, Singapore

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Past Delegate Special Discount*
Register 2 Delegates & the 3rd attends FREE!

overview

Key Learning Outcomes

  • Analyse global and regional biosimilars pipeline and growth markets
  • Understand what biosimilars financiers and sponsors are looking for
  • Guidelines, approvals and current regulatory challenges in ASEAN
  • Strategic consideration for success in the biosimilars market in Asia
  • Product portfolio and product life cycle analyses
  • Biosimilar drug development strategies
  • Regulatory approach, pricing and market access case studies
  • Safety and pharmacovigilance
  • Legal issues and risk management

Who Should Attend

This course is of practical importance for those involved in product portfolio development, clinical and non-clinical strategies, regulatory affairs, bioanalytics & biomanufacturing, drug safety, risk management & commercialisation

  • Commercial Leaders
  • Regulations & Compliance, RA, QA, QC
  • Clinical Strategy, Senior Research Scientists & Clinical Project Managers
  • Product Portfolio
  • Drugs Approval
  • Medical Manager
  • Patient safety and Patient affairs
  • Supply chain
  • Technical Services
  • Therapeutic product developer
  • Regulatory agency

Digital Badge

Upon completion of this training course, participants will earn a digital badge.

Earners of Biosimilars Certificate have acquired practical understanding of the commercial, regulatory environment in the Biosimilars market essential for analysing global and regional outlooks. They have practical knowledge in the Biosimimlar investment market, regulatory development with in-depth focus in Asia (e.g. GMP, regulatory audit, pharmacovigilance, naming & labelling); pricing & market access strategies; as well as non-clinical and clinical criteria in biosimilar drugs development.

Skills:
Biosimilars, drug development, GMP, regulatory affairs, pharma pricing, market access, clinical studies, non-clinical studies, pharmacovigilance, manufacturing considerations, ROI, investment outlooks, portfolio management.

Eligibility:
Attend and participate in the 2 full days of training course duration, led by the designated training expert

Available to:
Seminar attendees

Digital Badge FAQ >

trainer

Rodeina Challand

B.Sc., LLB., Challand Biosimilar Consulting Ltd

Joelle Chia

Asia Director, Pharma to Market Pte Ltd

Agenda

GLOBAL AND REGIONAL BIOSIMILAR CATEGORY ANALYSES

  • Global markets
  • Asean, India & China
  • Pipelines

THE BIOSIMILAR INVESTMENT MARKET

  • What are financiers looking for?
  • Where are the investments going?
  • Getting funding for biosimilars – key considerations
  • Investment and drug development partnerships

REGULATION AND DRUG DEVELOPMENT

  • Global regulations and guidelines
    • EU, US, LA, MENA, ROW Harmonisation or divergence?
    • Bioequivalence vs biosimilars
    • Is it working? – Case studies demonstrating uptake and volume increase

ASIAN MARKETS DEEP DIVE – GUIDELINES, APPROVALS AND OTHER REGULATORY MATTERS

  • ASEAN
  • India
  • China

STRATEGIC CONSIDERATIONS FOR SUCCESS IN THE BIOSIMILARS MARKET IN ASIA

  • GMP for biosimilars
  • Regulatory audit
  • Product choice
  • Manufacturing considerations
  • Cost analysis
  • In-house or CMO/
  • Quality comparability – regulatory expectations
  • Forecasting ROI

BIOSIMILAR DRUG DEVELOPMENT CRITERIA

  • From Cell line to Drug substance – cell banks
  • Quality comparability
  • Non-clinical comparability
  • Clinical comparability
  • Safety comparability
  • Post-marketing safety evaluation

NON-CLINICAL STUDIES

  • Animal studies
  • In-vitro biologic comparability

CLINICAL DEVELOPMENT

  • Phase I PK/PD
  • Bioanalytical
  • Safety and efficacy assessment phase III
  • Post-marketing
  • Extrapolated indications
  • Switching / interchangeability

MARKET ACCESS – REGULATORS’ CONSIDERATIONS

  • ASEAN
  • India
  • China
  • Case studies

CASE STUDY: PRICING AND MARKET ACCESS – STRATEGIC CONSIDERATIONS

SAFETY AND PHARMACOVIGILANCE

  • Evaluation of safety
  • Immunogenicity
  • Immunogenicity assays; safety and immunogenicity data
    • Post-apprvoal safety and PV systems Risk management plan
    • Pharmacovigilance plan
    • Post-marketing studies
    • Real world evidence data

NAMING AND LABELLING STRATEGIES

  • Propriety names
  • Identification
    • FDA guidance on labelling and prescribing information Labelling rules
    • Biosimilarity statement
    • Administration, preparation, storage and safety information
    • Product’s proprietar

LEGAL ISSUES AND RISK MANAGEMENT

  • Regulatory risk
  • Licensing risk
  • Speed-to-market risk

GROUP DISCUSSION: KEY SUCCESS FACTORS FOR BIOSIMILAR UPTAKES IN ASIA

when & where

25 - 26 Jul 2019

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
Email: aili.tan@meritushotels.com
Website: www.meritushotels.com

On-site & in-house training

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