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

24-26 Apr 2019

GBP 1,849
EUR 2,589
USD 2,884

Book now

Course Overview

PLEASE NOTE: THE VENUE FOR THE APRIL 2019 OUTING HAS NOW CHANGED TO THE HOLIDAY INN FORUM

This seminar will provide an 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 in Asia
  • 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 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 n 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. You will find this seminar useful both as an introductory and/or a refresher course. Previous delegates have included:

  • Scientists and technical staff in

- Regulatory affairs
- Registration departments

  • Medical directors

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

Presenters

Monica Dressler-Meyer

Mónica Dressler-Meyer is DRA Manager based in Switzerland with several 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.

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.

Book now

24-26 Apr 2019
24-26 Apr 2019 Holiday Inn London - Kensington Forum, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Actavis Group PTC
  • Actelion Pharmaceutical Ltd
  • AstraZeneca AB
  • Baxter SAS
  • Bayer Pharma AG
  • Biocompatibles UK Ltd
  • Bracco Imaging SpA
  • Chiesi Farmaceutici SPA
  • Chiron S.r.l
  • Dr Willmar Schwabe GmbH & Co
  • ELAN PHARMA LTD
  • Farmaprojects S.A.
  • Ferring Pharmaceuticals A/S
  • Galderma International
  • GlaxoSmithKline
  • Jadran Galenski Laboratorij d.d.
  • Kedrion SpA
  • Keyrus Biopharma
  • Leo Pharma A/S
  • Medicines and Healthcare Regulatory Agency
  • Mundipharma Research Ltd
  • NOVARTIS OPHTHALMICS AG
  • Novo Nordisk A/S
  • Pliva Croatia Ltd, Teva group
  • Reckitt Benckiser Healthcare (UK) Ltd
  • SERONO INTERNATIONAL SA
  • Shire Pharmaceutical Ltd
  • Solvay Deutschland GmbH
  • TILLEKE & GIBBINS INTERNATIONAL
  • UCB Pharma SA

The course was full of interesting information

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

Everything was very professional and well organised

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

Great speakers, great over 3 days, great knowledge

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

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

Christine Eliasson, Senior Regulatory Manager, BioGaia AB

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

Tania Castanheira, Reg Affairs Associate 1, Gilead Sciences International Ltd

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

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

Aurelia Signorelli, Regulaotry Affairs Manager, Specialised Therapeutics Australia Pty Ltd

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