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P40090 Pharma Regulatory Affairs
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Pharma Regulatory Affairs

22 – 23 April 2019 | Mandarin Orchard Hotel, Singapore

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REGISTER 2 DELEGATES & THE 3RD COMES FREE!

overview

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
  • Regulations and procedures for generics, biosimilars, orphan drugs, combination products, biologics
  • Understanding markets and exclusivity – what is being regulated
  • 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
  • Ethical and legal issues in the importation of unlicensed medication from overseas or over the internet at patient’s own risk
  • Emerging regulatory issues on data protection & privacy in the digitalisation of Pharma

Highlights of Dedicated Case Studies and Exercise:

  • Specific case studies on ASEAN launch of generics, biosimilars, biologics, orphan drugs and combination products, respectively
  • Examining OTC products’ regulatory strategies and Rx to OTC switch
  • ASEAN Pharmaceutical competition laws
  • Perspectives and strategies for accelerating drug approval in Asia

Who Should Attend

Professionals involved in Regulatory Affairs from Pharmaceutical companies, Pharma Marketing & Distribution firms, CMOs and CROs, including the following (but not limited to) functions:

  • Regulatory Affairs (Clinical and manufacturing functions)
  • Market access / Marketing
  • Clinical Development
  • Regulations & compliance
  • QA, QC
  • Research scientists
  • Pharmacovigilance
  • Drugs approval
  • Patient affairs
  • Supply chain

Testimonials

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

trainer

Chuan Yao

Principle Consultant, ChemPharm

Conrad Chong

Partner / Senior Consultant, ChemPharm

Joelle Chia

Asia Director, Pharma to Market Pte Ltd

Benjamin Gaw (LL.B.)

Head - Healthcare & Life Sciences, Drew & Napier

Agenda

Day One

SESSION 1: ESSENTIALS OF PHARMACEUTICAL REGULATORY AFFAIRS

  • Regulatory affairs primer
    • The main regulatory bodies
    • The function and evolutions of regulation
    • Move towards harmonisation – ICH

The life-cycle of a drug product Product development process

  • Nonclinical studies and Good Laboratory Practice
  • Clinical development and Good Clinical Practice

Product registration

  • Regulatory strategy
  • Regulatory Intelligence
  • Common Technical Document (CTD)
  • eCTD
  • CMC
  • Interacting with Regulators

Post marketing approval

  • Pharmacovigilance and risk management
  • Good Manufacturing Practice (GMP)
  • Variations and supplements
  • Advertising & Promotional Labelling

Regulatory issues in the digitalisation of Pharma

  • Data protection and privacy
  • Digital health technology

SESSION 2: REGULATORY STRATEGY – BIOLOGICS

  • Key terms related to Biologics
  • Large-molecule (biologic) therapies & trends
  • Different classes of biological products such as Vaccines, monoclonal antibodies and gene therapy
  • Regulation highlights
  • Steps to successful regulatory submissions

SESSION 3: REGULATORY STRATEGY – GENERICS AND BIOSIMILARS

  • Hatch-Waxman Act
  • Regulatory requirements for generics
  • What is Biosimilar
  • Biosimilar development process
  • Choosing the reference product
  • Regulatory pathways for the approval of biosimilars
  • Biosimilar vs. Generic

SESSION 4: REGULATORY STRATEGY – ORPHAN DRUGS

  • Rare disease development strategies
  • Orphan Drug designation (US, European, China)
  • Government incentives for Orphan Drugs
  • Develop a “fast to market” orphan regulatory strategy
  • Leverage academic and patient group to support Orphan Drug registration in China
  • Regulatory environment about Orphan Drug in China – rare disease list
  • China registration pathway
  • Case studies

SESSION 5: REGULATORY STRATEGY – COMBINATION PRODUCTS

  • What is Combination Products
  • Type of Combination Products
  • Similarities and differences in drug and device regulations
  • Early development considerations for Combination Products
  • Request for Designation (RFD)
  • Quality Management System for Combination Products
  • Regulatory route for Combination Product Approval
  • Case studies

REVIEW OF DAY 1 TOPICS AND QUESTIONS

Day Two

SESSION 6: RX TO OTC SWITCH

  • Trends in Rx-to-OTC switching
  • Advantages and disadvantages for switch
  • The Rx-to-OTC switch process
  • ASEAN country requirements
  • OTC labelling

SESSION 7: EMERGING TRENDS IN DRUG DEVELOPMENT AND REGULATORY CONVERGENCES IN ASIA PACIFIC

Guest Speaker: TBC

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
  • What’s next?

Focus on ASEAN – part 2

After registration ASEAN

  • Pharmacovigilance – monitoring safety
  • Individual country requirements

Variations

  • Definitions and Types
    • What is needed?

Pharmaceutical competition law

  • What are the issues?
  • ASEAN focus

SESSION 8: REGULATORY ISSUES IN PHARMA (ASEAN)

Guest Speaker: TBC

  • Current law and practices
  • Ethical and legal issues in the importation of unlicensed medication from overseas or over the internet at patient’s own risk
  • Balancing individual/society interests with business & corporate interests

SESSION 9: SUPPLY CHAIN, PACKAGING AND LABELLING

  • Current regulatory issues
  • The Falsified Medicines
  • Directive requirements in practice
  • Patient compliance and safety
  • Serialisation of pharma folding cartons
  • Special requirements – readability, braille, child proof, tamper evidence

Packaging – the patient to business interface

  • Primary packaging
  • Secondary packaging
  • ISO 15378:2017 Primary packaging materials for medicinal products
  • Concept of patient compliant packaging

Artwork and labelling

  • Implementing a GMP compliant artwork process
  • Labelling for safety

REVIEW OF DAY 2 TOPICS AND QUESTIONS

when & where

22 - 23 Apr 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

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