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Pharmaceutical

Pharmaceutical Regulatory Affairs in Asia

4-6 Apr 2018

GBP EUR USD
Standard 1849 2589 2884
Excluding VAT @ 20.00%

Venue: Rembrandt Hotel, London

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Bespoke training

We can customise this course to meet the requirements of your organisation.

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Course Overview

BENEFITS OF ATTENDING

  • Gain an overview of the Asian Markets
  • Discuss outlines of company and product registration
  • Understand the Application Process
  • Assess the impact of recent regulatory developments in the region
  • Discuss harmonisation initiatives including ASEAN opportunities
  • Understand how Japan fits in the Asian regulatory landscape
  • Discover general country specific and regional requirements

Why you should attend

This seminar wil provide an overview of the key areas of pharmaceutical regulatory affairs in Asia, including India.

Who should attend

This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance. You will find this seminar useful both as an introductory and/or refresher course.

Personnel from Analytical Research and Development, Clinical Development, Quality Assurance, new business development departments, regulatory authorities.

Meeting Timings

DAY ONE

09.00 Registration and coffee
09.30 Meeting start
17.00 Meeting end

DAY TWO

09.00 Meeting start
17.00 Meeting end

DAY THREE

09.00 Meeting start
16.30 Meeting end

Programme

Day 1: China, Hong Kong SAR, Introduction to ASEAN, Brunei and the Philippines
Day 2: India, Indonesia, Malaysia, Singapore and Thailand, Cambodia, Laos, Vietnam
Day 3: Taiwan, Korea, brief comparison of Japan, ASEAN harmonisation

The Markets

  • Brief Commercial and Cultural Background
  • Importance of Major Markets

Company and Product Registration

  • Regulations and Guidelines
  • Drug Classification Systems
  • Site Registration
  • New Products
  • Line Extensions
  • Labelling Changes
  • Sourcing Changes
  • Registration Samples
  • Certificates / Legalisation

Application Process

  • Committees / Meetings
  • New Applications
  • Variations
  • Renewals / Re-registration

Recent Regulatory Developments

  • Influences and Changes: national and regional
  • The latest Regulatory Developments in the region

Harmonisation Initiatives

  • ASEAN Opportunities

A Brief comparison of how Japan fits into the Asian regulatory landscape

General Country-Specific and Regional Discussions

Previous customers include...

  • Actavis Group PTC
  • APOGEPHA ARZNEIMITTEL GMBH
  • AstraZeneca AB
  • Biocompatibles UK Ltd
  • Celgene Europe Ltd
  • Centocor BV
  • CJ CORP
  • Consultant
  • Dr Willmar Schwabe GmbH & Co
  • ELAN PHARMA LTD
  • Ferring Pharmaceuticals A/S
  • Galderma International
  • GE Healthcare AS
  • Ginsana SA
  • Helm AG
  • Keyrus Biopharma
  • Laboratorios Almirall S A
  • LEK Pharmaceuticals d.d.
  • Mundipharma Research Ltd
  • Napp Pharmaceutical Group Ltd
  • Novo Nordisk
  • S.A. ALCON-COUVREUR N.V.
  • Sandoz GmbH
  • Sanofi Synthelabo Recherche
  • Sanofi-Aventis Recherche & Development
  • Science Union SA
  • SERONO INTERNATIONAL SA
  • TILLEKE & GIBBINS INTERNATIONAL
  • UCB Pharma SA
  • Xellia Pharmaceuticals AsP