Glaxo Wellcome UK Ltd.

DUBLIN--( BUSINESS WIRE )--The "Pharmaceutical Regulatory Affairs in China Training Course" conference has been added to ResearchAndMarkets.com's offering. This seminar will provide an invaluable overview of how to gain and maintain a successful pharmaceutical marketing authorisation in the People's Republic of China (PRC), including Hong Kong, Macau and Taiwan. The two-day course offers a comprehensive overview of critical components necessary for obtaining and preserving successful marketing authorization within the region. It will delve into the recent regulatory reforms and the drug regulatory systems that impact this process. Participants will gain insights into both import and local manufacture registration procedures, alongside detailed coverage of clinical product development, including Chemistry, Manufacturing, and Controls (CMC) regulatory requirements. The course also provides a practical interpretation of these topics, aiming to equip attendees with applicable knowledge. Additionally, it offers a valuable platform for delegates to exchange experiences, enhancing learning through shared insights and discussions. 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 in this region. You will find this seminar useful both as an introductory or refresher course. Previous delegates have included scientists and technical staff in regulatory affairs and registration departments, medical directors, and personnel from analytical research and development, clinical development, quality assurance, new business development and regulatory authorities. Benefits of attending: Gain an overview of the regulatory procedures in the region Understand and assess the impact of recent regulatory reforms Discuss clinical product development and Chinese-specific approaches Understand requirements for import and local manufacturing registration Discuss product registration strategies Certifications: CPD: 12 hours for your records Certificate of completion Agenda: Day 1 General introduction to the PRC and the pharmaceutical market Commercial and cultural background P.R. China - Drug Regulatory Systems Regulatory authorities Recent regulatory changes Regulations and guidelines Drug classification systems Import and local manufacture registration Data requirements Registration requirements Labelling requirements P.R. China - Clinical Product Development Regulatory aspects of clinical development Recent regulatory changes Documentation needs including CMC Regulatory requirements including GCP aspects Chinese-specific approaches Multinational clinical trials Hong Kong SAR Background overview Regulatory authorities Regulatory requirements and procedures Specific market aspects Macau SAR Brief overview of regulatory aspects Day 2 P.R. China - Regulatory Strategies P.R. China - Health Authority Interactions P.R. China - Maintenance Taiwan (Republic of China) Cultural background Regulatory authorities Regulations and guidelines Drug classification systems Data requirements Country-specific matters P.R China - Recent Developments Speakers: Mónica Dressler-Meyer DRA Manager Management Forum Mónica 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. Mónica has a Degree in Chemistry and Biochemistry from Basel University. Alan Chalmers Pharmacist Management Forum 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. For more information about this conference visit https://www.researchandmarkets.com/r/smaxv9 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

DUBLIN, April 20, 2023 /PRNewswire/ -- The "Pharmaceutical Regulatory Affairs in China Training Course" conference has been added to ResearchAndMarkets.com's offering. This seminar will provide an invaluable overview of how to gain and maintain a successful pharmaceutical marketing authorisation in the People's Republic of China (PRC), including Hong Kong, Macau and Taiwan. The two-day course will cover: All important aspects of gaining and maintaining a successful marketing authorisation in the region Recent regulatory reforms Drug regulatory systems An overview of import and local manufacture registration Clinical product development including CMC regulatory requirements An interpretation of practical aspects The opportunity to exchange experiences with other delegates Benefits of attending: Gain an overview of the regulatory procedures in the region Understand and assess the impact of recent regulatory reforms Discuss clinical product development and Chinese-specific approaches Understand requirements for import and local manufacture registration Discuss product registration strategies 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 in this region. You will find this seminar useful both as an introductory or refresher course. Previous delegates have included scientists and technical staff in regulatory affairs and registration departments, medical directors, and personnel from analytical research and development, clinical development, quality assurance, new business development and regulatory authorities. Key Topics Covered: Day 1 General introduction to the PRC and the pharmaceutical market Commercial and cultural background P.R. China - Drug Regulatory Systems Regulatory authorities Recent regulatory changes Regulations and guidelines Drug classification systems Import and local manufacture registration Data requirements Registration requirements Labelling requirements P.R. China - Clinical Product Development Regulatory aspects of clinical development Recent regulatory changes Documentation needs includingCMC Regulatory requirements includingGCPaspects Chinese-specific approaches Multinational clinical trials Hong Kong SAR Background overview Regulatory authorities Regulatory requirements and procedures Specific market aspects Macau SAR Brief overview of regulatory aspects Day 2 P.R. China - Regulatory Strategies P.R. China - Health Authority Interactions P.R. China - Maintenance Taiwan (Republic of China) Cultural background Regulatory authorities Regulations and guidelines Drug classification systems Data requirements Country-specific matters P.R China - Recent Developments Speakers: Monica Dressler-Meyer DRA Manager Management Forum Mónica 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. Mónica has a Degree in Chemistry and Biochemistry from Basel University. Alan Chalmers Pharmacist Management Forum 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. For more information about this conference visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

DUBLIN--( BUSINESS WIRE )--The "Pharmaceutical Regulatory Affairs in Asia Training Course" conference has been added to ResearchAndMarkets.com's offering. 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 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. 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 Please note that the course will provide an excellent introduction to all the key aspects of regulatory affairs in the Asia region but will not focus specifically or in detail on Chemistry, Manufacture and Control (CMC). 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 Key Topics Covered: 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 Speakers: Monica Dressler-Meyer DRA Manager Management Forum Mónica 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. Mónica has a Degree in Chemistry and Biochemistry from Basel University. Alan Chalmers Pharmacist Management Forum 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. For more information about this conference visit https://www.researchandmarkets.com/r/ylz978 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.