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Live Online: Pharmaceutical Regulatory Affairs for EU and China

23-26 November 2020 | 4-Day Live Online | 1:30 pm – 5:30 pm (SGT)
2 Separately Bookable Programmes, Each with Regional Focus

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overview

2 Separately Bookable Programmes, Each with Regional Focus

About the Course

In the heavily regulated, rapidly changing environment of pharmaceutical industry, staying informed with requirements and guidelines maintained by different authorities is crucial to sponsors, CROs/CMOs and distributors. Complex and challenging, the success in clinical approvals, dossier submission, pharmacovigilance, product filing, among other operations, allow you to accelerate market access and achieve bottom line.

Catering to pharmaceutical executives maintaining regulatory compliance, this live-online masterclass explores key touchpoints across European and Chinese regulatory systems, respectively. Each with its own regional focus, the two separately bookable training units offer attendees in-depth examination into latest regulatory reforms, legislative developments, including data privacy, labelling & packaging, post-MAA obligations, import & manufacturing registrations, fast-track approvals, as well as key legal issues.

 

Key Learning Outcomes & Case Studies Include

Regulatory Affairs for Europe

  • Overview of regulatory bodies & competent authorities; legislative systems, EU pharma/medical law
  • Clinical Trial regulations (data requirements, ethics committees; CTR 2014, ICH GCP; differences within EU; IRB)
  • Clinical Trial Approval Process
  • Product Development regulations (Non-clinical studies vs Clinical studies)
  • Dossier submission process including standards required by the regulators
  • Common Technical Document (CTD) and eCTD
  • Labelling and packaging regulations
  • Marketing Authorisation Applications (CP, DCP, MRP, National Procedures)
  • Post-MAA obligations product & variation filing, Pharmacovigilance and lifecycle management
  • Understanding abridged applications
  • Best practices: registration strategies for your products
    • Case studies: biosimilars, oncology, OTC, generics
  • Working effectively with EMA
  • Legal issues (product recalls, CT violations, data manipulations, data privacy etc)

 

Regulatory Affairs for China

  • Industry structure and key stakeholders
  • Market Updates (pharma/medical law, import vs local manufacture registration, impacts of trade wars)
  • Key insights on China’s Reformed Drug Administration Law (market authorization holder system, online prescription sales, counterfeit definition, penalties, etc)
  • Product development & registration routes (Compliance, differences with EU/US)
  • CMC requirements
  • Ethics committees (EC) process
  • Marketing Authorisation Application and case studies
    • Case studies: Chemical vs biological drugs
  • Post-approval Lifecycle Management, Variations & renewals
  • eCTD implementation
  • Pharmacovigilance requirements
  • Packaging & labelling requirements in China
  • Best practices and case studies for success in registering new drugs
  • NMPA Interactions & Recent Regulatory Developments
  • Differences in drug registration in HK/Macau SARs
  • Legal issues

Course Directors

Dr. Salma Michor (PhD, MSc, MBA, CMgr, RAC-Treasurer)
CEO, Michor Consulting

View profile »

 

 

Joanna Han
Director
Zen Medical Science Consultancy

View profile »

Live Online Learning

Stay Home. Skill Up!

The current Covid-19 pandemic has put strains on various areas of business, especially when it comes to deriving commercial value from new initiatives. During this phase of self-isolation and working from home, we can help you meet your professional development needs and you can still take your professional development plans to the next level.

To support your learning goals we have converted our face-to-face trainings to LIVE Online Sessions. This way you can continue to attend live and interactive training sessions within the virtual classroom space where you can see and speak, with your Subject Matter Expert and other participants.

Benefits of Live Online Learning

Aimed at offering you immediate, high-quality practical information whilst minimising time and expenditure associated with travelling, our digital training platform enables you to interact in real time with course directors and remotely network with your fellow participants.

  • Classroom Experience: Progress with fellow participants as you would in an on-site class
  • Guaranteed cost-effectiveness: Travel budget saving, plus 20% price advantage for online participation
  • Controlled environment with speakers managing the Q&A and discussions and tools for enhanced interactions
  • Module-based approach to effectively manage your time and revisions
  • Earn your Digital Certification and broadcast your achievements to your peers
  • Onboarding: Available for all attendees
  • Proven and secure training platform

 

Click here to know more >

Digital Badge

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

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

Available to:
Seminar attendees

Digital Badge FAQ >

Agenda

Regulatory Affairs for Europe (Modules 1 and 2)

Overview of EU Regulatory Framework

  • Regulatory Bodies and Competent Authorities
  • Legislative system
  • EU pharma law

Product Development – Non-Clinical Studies

  • The Target Product Profile
  • Non-clinical development
  • Toxicology
  • Pharmacokinetics and toxicokinetics
  • Environmental risk assessment

Product Development – Clinical Studies

  • Clinical trial directive
  • Regulations
    • Ethics Committees, IRB
    • Data requirements
    • CTR 2014
    • ICH GCP
    • Difference between EU countries
    • GCP
  • Data protection

Marketing Authorisation Application

  • Regulatory Procedures
    • Centralised procedure & decentralised procedure
    • Mutual recognition procedure
    • Case studies: Orphan drugs, advanced therapies, etc
    • Scientific advice
  • Registration dossier
    • GxP and MA dossier
    • CTD and eCTD requirements
    • CMC module

Labelling & Packaging Requirements

  • Packaging & labelling guidelines
  • Patient information leaflets PILs in Europe
  • SmPC
  • Serialisation of Pharma Folding Cartons
  • Track-and-trace solutions
  • Readability guidelines

Post-MAA: filing variations and renewals

  • Introduction to filing variations
  • Variations requirements and procedures
  • Compare the different types of variations: Type IA, IB, and II
  • Variations vs extensions
  • Renewal legislation and procedures

Pharmacovigilance Obligations

  • Good pharmacovigilance practices
  • Periodic safety update reports (PSURs)
  • Risk management plan and post-authorisation safety studies (PASS)

 Practical Considerations

  • Working effectively with EMA
  • Understanding abridged applications
  • Legal issues

 


 

Regulatory Affairs for China (Modules 3 and 4)

Pharmaceutical Industry in China

  • Legal, socioeconomic background influencing pharma industry
  • industry supply chain, key players
  • Market updates
    • Import vs local manufacture registration
    • Exports
    • Impacts of trade wars and Covid-19
  • Drug administration law and regulations

China Regulatory Agencies, Legal & Regulatory Background

  • NMPA interactions
  • Comparative perspectives: How China’s regulations differ from EU and FDA
  • Reformed Drug Administration Law (DAL) and Amended Drug Registration Regulation (DRR)
    • Risk management of clinical research and drug safety
    • Managing changes in clinical protocols and pharmacology
    • Accelerated approval pathways
    • Marketing authorisation holder
    • Classification of changes in drug production
    • Conditional approval for new drugs

Clinical Trial Applications

  • Clinical trials overview in China
  • EU studies considered in China
  • Acceptance of overseas data for market authorisation
  • Ethics committees (EC) process
  • CMC requirements

Marketing Authorisation Applications

  • Product registration and procedures in China
    • Chemical drugs
    • Biological drugs, biosimilars
    • Difference with EU & FDA
  • Regulatory procedures post DAL
  • eCTD implementation
  • Life-cycle management of product registrations
  • China’s perspective on RWE
  • Differences in drug registration in HK/Macau SARs

Post-approval Lifecycle Management

  • Pharmacovigilance requirements
  • Variations & renewals

Supply Chain, Packaging & Labelling Requirements

  • China’s requirements
    • Differences with EU and FDA
  • Packaging & Labelling compliant programmes
  • Online prescription sales
  • Counterfeit definition
  • Penalties and legal issues

Best practices and case studies for success in registering new drugs

  • Common challenges and pitfalls
  • Case studies: OTC, Biosimilars, Generic products
  • Risk identification & Mitigation

 Legal Issues

  • Product recalls
  • Clinical trial violation
  • Data manipulations, data privacy

when & where

23 - 26 Nov 2020

4-Day Live Online
1:30 pm – 5:30 pm (SGT)

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

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