Presented by
Management Forum

Pharmaceutical Regulatory Affairs in Asia

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

15-17 Nov 2021 + 2 more dates

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  • Format: Live online
  • CPD: 18 hours for your records
  • Certificate of completion

Course Overview

The pharmaceutical market in Asia is growing at a rapid pace and presents both opportunities and challenges to those wishing to work in the region. Rather than a single market, Asia is a collection of different markets, each with their own regulatory processes, although harmonisation exists within the ASEAN countries.

This seminar will provide a practical overview of the key areas of pharmaceutical regulatory affairs in Asia, including India, and will cover all important aspects of gaining and maintaining a successful marketing authorisation within the region.

The programme will include:
  • Discussion of underlying official regulatory sources
  • An interpretation of practical aspects
  • An overview of the requirements for local manufacturing
  • Recent developments
  • Harmonisation initiatives
  • An update and wider knowledge of regulatory affairs in Asia
  • The opportunity to exchange experiences with other delegates

Benefits of attending:

  • Gain an overview of key 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

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, whether as an introductory or a refresher course.

Previous delegates have included:
  • Scientists and technical staff in
    • Regulatory affairs
    • Registration departments
  • Medical directors

Programme

The programme consists of regional presentations covering:

  • 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

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The Pharmaceutical Regulatory Affairs in Asia course will cover:

Introduction to the Asia Region

Introduction to ASEAN

Philippines

Brunei

PR of China

India

Malaysia

Singapore

Hong Kong

Indonesia

Thailand

Vietnam / Cambodia / Laos

Taiwan

Korea

Outline on Japan

Asean Harmonisation

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Monica Dressler-Meyer

Mónica Dressler-Meyer is DRA Manager based in Switzerland with many years of regulatory experience. She has spent many years in DRA working with different pharmaceutical companies with responsibility for Asia Pacific and lately also for development activities in other regions. Prior to this, she worked at F. Hoffmann-La Roche in Switzerland where she gained several years’ experience in industry basics and pre-clinical research. She has a Degree in Chemistry and Biochemistry from Basel University.

More details

Alan Chalmers

Dr Alan Chalmers is a pharmacist with over 35 industrial experiences mainly in the field of pharmaceutical regulatory affairs. A graduate of Strathclyde University in Glasgow with a B.Sc. in Pharmacy with specialisation in Pharmaceutical Technology, his Ph.D. at Manchester University was in Pharmaceutical Formulation. From 1975-1978 he was Development Officer and Clinical Trials Pharmacist of Allen & Hanburys (part of the then Glaxo group). In 1978 he joined Ciba-Geigy in DRA. Over 20 years were spent with Ciba-Geigy/CIBA/Novartis in all aspects of regulatory affairs including head of a group company DRA in Canada and for many years as Head of Pharma International regulatory affairs.

He has been consultant to the IFPMA, WHO and other international bodies and was Chairman of the Organising Committee of the initial IFPMA Asian Regulatory Conferences in Hong Kong and Singapore and Rapporteur to the more recent conferences in China and Malaysia.

Since 1998 he has been an independent regulatory consultant and is Director of his own consultancy company Pharma International in Switzerland. He has also been director of two UK and Swiss registered pharmaceutical companies with specialised responsibility for international regulatory strategy. More recently as accredited by Swissmedic, Dr. Chalmers is a Qualified Person supporting several Swiss pharmaceutical companies trading internationally with pharmaceuticals and medical devices.

He is published, and his publications include a textbook on International Pharmaceutical Registration, Active Pharmaceutical Ingredients and as Swiss correspondent to the Regulatory Affairs Journals Pharma and Medtech. Since 2012 he has been a member of the Editorial Board, Scrip Regulatory Affairs.

More details

Book Pharmaceutical Regulatory Affairs in Asia Live online training

15-17 Nov 2021

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 11919

  • GBP 1,549
  • EUR 2,229
  • USD 2,524

In your basket 

20-22 Apr 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11596

  • GBP 1,249 1,549
  • EUR 1,809 2,229
  • USD 2,056 2,524

Until 16 Mar

In your basket 

12-14 Oct 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11920

  • GBP 1,249 1,549
  • EUR 1,809 2,229
  • USD 2,056 2,524

Until 07 Sep

In your basket 

Reviews of IPI's Pharmaceutical Regulatory Affairs in Asia training course


Good, helpful.

Apr 7 2021

Sarah Elisabeth Snedeker
Project Leader, CHIESI FARMACEUTICI SPA

Apr 24 2019

Both are very experienced on these countries with high knowledge on the regulatory aspects. I can say that my opinion of the course is very positive.

Sonia Dias
Regulatory Affairs Officer, BIAL - Portela & Ca, S.A.

Apr 24 2019

I think the content is very good, even though very extensive

Karina Kück
Graduate Regulatory Professional, H. Lundbeck A/S

Apr 24 2019

Very good, and extensive knowledge in the area, very impressive. Very, very good course, learnt a lot.

Pernille Træholt
Head of Regulatory Affairs and QA, Pharmanovia A/S

Apr 24 2019

A good overview about RA in Asia - the classes given by Monica were a joy to attend!

Andrea Gießmann
Regulatory Affairs Manager, HELM AG

Apr 4 2018

Everything was very professional and well organised

Anca-Maria Perian
Regulatory Affairs Manager International, Cesra Arzneimittel GmbH & Co. KG

Apr 4 2018

The course was full of interesting information

Tanja Hammen
Manager Regulatory Affairs, Engelhard Arzneimittel GmbH & Co. KG

Apr 4 2018

Great speakers, great over 3 days, great knowledge

Marta Parmar
‎Regulatory CMC Lead, Global Emerging Markets, Biogen International GmbH

Apr 4 2018

high speed and a lot to take in. But very useful information

Christine Eliasson
Senior Regulatory Manager, BioGaia AB

Apr 19 2017

I was pleased with the course in terms of content, presentation and speakers

Aurelia Signorelli
Regulaotry Affairs Manager, Specialised Therapeutics Australia Pty Ltd

Apr 19 2017

Excellent contents of regulatory requirements in the region with very good ideas on new requirements and challenges

Salah Chettibi
Regulatory Affairs Manager, Kyowa Kirin International plc

Apr 19 2017

Really good. I do not come from a regs background and some of the content went over my head however even without any prior knowledge I found the course very helpful and could take a lot of information away with me. It was all pitched correctly

Erika Ravitz
Artwork Co-ordinator, Eisai Manufacturing Limited

Apr 19 2017

Monica is brilliant love her enthusiasm and the way she manages the presentation

Tania Castanheira
Reg Affairs Associate 1, Gilead Sciences International Ltd

UK

  • Torbay Pharmaceuticals
  • Actavis UK Ltd
  • AstraZeneca UK Ltd
  • Atnahs Pharma UK Ltd
  • Atnahs Pharma UK Ltd.
  • Biocompatibles UK Ltd
  • Biogen Idec
  • Business Monitor International Ltd
  • Celgene Europe Ltd
  • Clifford Chance LLP
  • Eisai Manufacturing Limited
  • ELAN PHARMA LTD
  • GE Healthcare Ltd
  • Gilead Sciences International
  • Gilead Sciences International Ltd
  • GlaxoSmithKline
  • Kyowa Kirin International plc
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MSD
  • Mundipharma Research Ltd
  • Napp Pharmaceutical Group Ltd
  • Pharm Research Associates UK Ltd
  • Prostrakan Group Ltd
  • pSivida
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Shire Pharmaceutical Ltd
  • Smith & Nephew Wound Management
  • Takeda Development Centre Europe Ltd
  • Vectura

France

  • Altran Technologies
  • Baxter SAS
  • Becton Dickinson
  • Galderma International
  • Guerbet
  • Horus Pharma
  • Ipsen Pharma SAS
  • Keyrus Biopharma
  • Mylan sas
  • Sanofi Pasteur SA
  • Sanofi Synthelabo Recherche
  • Sanofi Winthrop Industrie
  • Sanofi-Aventis
  • Sanofi-Aventis Recherche & Development
  • Science Union SA

Germany

  • APOGEPHA ARZNEIMITTEL GMBH
  • Bayer Pharma AG
  • Cesra Arzneimittel GmbH & Co. KG
  • Cheplapharm Arzneimittel GmbH
  • Dr Willmar Schwabe GmbH & Co
  • Engelhard Arzneimittel GmbH & Co. KG
  • Engelhard Arzneimittel GmbH KG
  • Grunenthal GmbH
  • Helm AG
  • Merck Kga A - Werk Darmstadt
  • Merck KGaA
  • Solvay Deutschland GmbH
  • STADA Arzneimittel AG

Switzerland

  • Actelion Pharmaceutical Ltd
  • APR Applied Pharma Research sa
  • Biogen International GmbH
  • Cerbios-Pharma SA
  • CSL Behring AG
  • F. Hoffmann-La Roche Ltd
  • Ginsana SA
  • Mundipharma Laboratories GmbH
  • NOVARTIS OPHTHALMICS AG
  • SERONO INTERNATIONAL SA
  • Valeant Pharma Switzerland GmbH

Denmark

  • Ferring Pharmaceuticals A/S
  • H. Lundbeck A/S
  • Leo Pharma A/S
  • Novo Nordisk A/S
  • Novo Nordisk Pharmatech
  • Pharmanovia A/S
  • Xellia Pharmaceuticals AsP

Italy

  • Antibioticos
  • Bracco Imaging SpA
  • Chiesi Farmaceutici SPA
  • Chiron S.r.l
  • GlaxoSmithKline Vaccines & Diagnostics s.r.l.
  • Kedrion SpA

Belgium

  • Glaxo Smithkline Biologicals
  • Janssen Pharmaceutica NV
  • S.A. ALCON-COUVREUR N.V.
  • UCB Pharma SA

Netherlands

  • Abbott Healthcare Products BV
  • Centocor BV
  • CHIRON BV
  • Janssen Biologics BV

Spain

  • FAES FARMA, S.A.
  • Farmaprojects S.A.
  • GRIFOLS S.A.
  • Laboratorios Almirall S A

Australia

  • BOC Limited member of Linde Group
  • Specialised Therapeutics Australia
  • Specialised Therapeutics Australia Pty Ltd

Sweden

  • AstraZeneca AB
  • BioGaia AB
  • Pharmacia AB - Helsingborg

Austria

  • Octapharma Pharmazeutika Produktionsges.m.b.H.
  • Sandoz GmbH

Croatia

  • Jadran Galenski Laboratorij d.d.
  • Pliva Croatia Ltd, Teva group

Finland

  • Borealis Polymers Oy
  • Orion Oyj

Hong Kong

  • AVENTIS BEHRING ASIA PACIFIC LTD

Hungary

  • CHINOIN Private Co. Ltd.

Iceland

  • Actavis Group PTC

Israel

  • TRIMA PHARMACEUTICAL PRODUCTS

Korea, Republic Of

  • CJ CORP

Norway

  • GE Healthcare AS

Poland

  • Adamed Pharma S.A.

Portugal

  • BIAL - Portela & Ca, S.A.

Singapore

  • Novo Nordisk Asia Pacific Pte Ltd

Slovenia

  • LEK Pharmaceuticals d.d.

Thailand

  • TILLEKE & GIBBINS INTERNATIONAL

Ukraine

  • Yuria-Pharm LLC

United States of America

  • PHARMACIA CENTRESOURCE

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy