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20-04-2020 (Singapore)

P40107 Pharma Regulatory Affairs Risk Management
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Pharma Regulatory Affairs Risk Management

20 – 21 April 2020 | Mandarin Orchard Hotel, Singapore

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Team Savings: Register 2 Delegates & the 3rd Comes free!
Early Bird Rate: Register & Pay by 28 February 2020

overview

Key Learning Outcomes & Case Studies Include

  • 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

Who Should Attend

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

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

pricing

Packages Price
2 Day TrainingSGD $3595SGD $3395Early BirdEarly Bird

Early Bird Rate: Register & Pay by 28 February 2020

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate of 2-day main conference package only.
For Group Registrations, email register@informa.com or call +65 6508 2401

 

  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.
  • View payment terms and bank transfer details, click here »

Trainer

Chuan Yao
Principle Consultant
ChemPharm

Chuan Yao, has over 25 years of experience in the pharmaceutical and medical device industry and has worked in the industry in China, New Zealand, Australia, Singapore and other ASEAN countries. Chuan has held senior positions in the areas of Quality Assurance, Regulatory Compliance and Regulatory Affairs and has been responsible for maintenance of regulatory compliance of active ingredient manufacturer’s drug master files (DMF) and European certificates of suitability (CEPs). Chuan also has extensive analytical testing and quality control experience, production engineering experience involving trouble shooting, process optimization and long-term process/ product development activities. Chuan also has experience in GMP compliance auditing while employed by China State Food and Drug Administration (CFDA). In this role Chuan conducted for regulatory audits to Chinese pharmaceutical companywithin mainland China. Following his professional experiences at CFDA, Pacific Pharmaceuticals (New Zealand, now Merck Group), Go Medical Industries (Australia), Wyeth (Singapore, now Pfizer), Chuan Yao is currently a principal consultant in ChemPharm, and leading consultant team to participate GMP/ GLP/GDP/GVP projects in mainland China, Hong Kong, Taiwan, Australia, New Zealand and ASEAN countries. Chuan has a wealth of knowledge in regulatory compliance, validations, project management, GMP/GLP/GDP/GVP and regulatory affairs, he has designed and conducted series of GxP training courses to train thousands of industry professional. Chuan was a Drug Abuse Inspector with the China Drug Control Center, Beij ing, China and was appointed to the position of a drug inspector at the Beijing 11th Asian Games in which he was awarded an Honorary Diploma from the Olympic Committee. Chuan is fluent in English and Chinese.

Area of Expertise:

  • USFDA, CFDA, PIC/s, EU GMP, GxP and ISO Compliance
  • Quality Assurance and Risk Assessment in Pharmaceuticals and Medical Devices
  • Compliance Auditing and Gap Analysis
  • Regulatory Affairs and Regulatory Compliance
  • GxP Training
  • Analytical Testing
  • Process Capability
  • Medical Devices – ISO13485 and 21 CFR Part 820

Agenda

SESSION 1: ESSENTIALS OF PHARMACEUTICAL REGULATORY AFFAIRS

  • Regulatory affairs primer
    • The main regulatory bodies
    • The function and evolutions of regulation
    • Moves 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 digitalization 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: REGULATOR 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

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

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)

  • Overview on marketing and advertising rules of pharmaceutical products
  • Online sale of pharmaceutical products and potential risks and issues
  • Overview of key issues in pharmaceutical distribution agreements

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

when & where

20 - 21 Apr 2020

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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