2021CPhI国际药政答疑会（法规更新专题）

热门推荐： CPHI国际药政答疑会 , 国际监管要求 , 法规更新专题 ,

来源：CPhI世界制药原料中国展

2021-12-15

为不断提高中国医药行业质量体系，更好地服务于全球患者的需求搭建平台，使中国业界能够更好地了解国际监管要求，为中国企业以多种形式参与国际化发展提供强有力的支持，中国医药保健品进出口商会将于2021年12月15日14:00-17:00以线上会议形式举办2021CPhI国际药政答疑会（法规更新专题）。

2021CPhI国际药政答疑会

药典标准有哪些变化？监管机构的最新关注是什么？疫情下的现场检查如何开展？除化学制剂之外，在原料药、辅料、包材和在生物药方面，国际机构有哪些关注？药政官员和行业专家将一一为企业做解答。

会议免费，报名需审核

仅限CPhI&P-MEC中国展展商参加

法规更新专题

12月15日重磅嘉宾

Juliette Taylor

Juliette Taylor

PharmD, MBA, RAC, BCPP

Captain (CAPT), United States Public Health Service

FDA China Office, Office of Global Policy and Strategy, U.S. Food and Drug Administration

Dr. Taylor currently serves an Acting Assistant Country Director at the US-FDA China Office. She brings over 18 years of policy, clinical, and teaching experience with the Food and Drug Administration (FDA), Centers for Medicare & Medicaid Service (CMS), academia, and private sector. She has a proven track-record of successfully leading teams in developing and implementing new policy and legislation, international harmonization, domestic and international stakeholder engagement, contractor management, and managed care consulting. She has extensive experience with application reviews and liaising with pharmaceutical industry on Investigational New Drug (IND) and New Drug Applications (NDA) at FDA. She has represented FDA and CMS, presenting at large national and international conferences. Over the course of her career as a United States Public Health Service officer, she has served on multiple deployments in response to national emergencies as a mental health team pharmacist.

Hélène Bruguera

Hélène Bruguera

Head of the Certification Department

Co-chair of the IPRP Quality Working Group (QWG)

Mrs Hélène Bruguera graduated in Biochemistry from the University of Nancy, France and has a Master in Industrial Pharmacy from the University of Strasbourg, France.

She worked for the pharmaceutical industry for 10 years in analytical development and in the preparation of the quality part for marketing applications.

She joined the EDQM in year 2000, and is currently the Head of the Certification Department. She deals with the management of CEP applications as well as the EDQM inspection programme for API manufacturers. She is also involved in international platforms related to the quality of medicines and active pharmaceutical ingredients (ICH, IPRP), and is currently co-chair of the IPRP Quality Working Group (QWG).

Hua YIN

Hua YIN

Technical officer, Regulation and Prequalification Department (RPQ), World Health Organization

Mrs. Hua YIN has worked with WHO prequalification of medicines programme since 2006, as a senior assessor focus on the quality of the pharmaceutical products. Before joining WHO, she worked in National Institute for Food and Drug control of China and Chinese Pharmacopoeia Commission in the area of quality control of pharmaceutical products.

Dr. MartinO'Kane

Dr. MartinO'Kane

Head of the Clinical Trials Unit at the Medicines and Healthcareproducts Regulatory Agency (MHRA)

Dr Martin O'Kane MRPharmS is Head of the Clinical Trials Unit at the Medicines and Healthcare products Regulatory Agency (MHRA). He studied pharmacy at University of Aston and after completing a PhD and post-doctorate research project at the University of Glasgow, he moved to Japan to work within the pharmaceutical industry. He joined the MHRA in 2005 as a Pharmacopoeial Scientist within the British Pharmacopoeia and moved to the MHRA Clinical Trials Unit (CTU) as a Pharmaceutical Assessor in 2007. He became Head of CTU in November 2015 and is actively involved in European and UK projects to prepare for implementation of the new clinical trials Regulations.

Jesusa Joyce N. Cirunay

Jesusa Joyce N. Cirunay

Director IV of the Center for Drug Regulation and Research at the Food and Drug Administration Philippines

She is currently the Director IV of the Center for Drug Regulation and Research at the Food and Drug Administration Philippines. Her government service began at the Product Services Division (PSD) covering Marketing Authorizations as Pharmaceutical Researcher then as Senior Drug Evaluator including New Drug Applications and Vaccines. Her repertoire also covers experiences in international collaboration as former OIC–FDA International Affairs Office; media relations as former FDA Spokesperson; Quality Management System as former Quality Manager for the FDA Quality Management System on ISO 9001 initially for 2008 version and then 2015 version; on ASEAN Harmonization in the Healthcare Sector representing FDA PH as Head of Delegation or Delegate; on APEC as Delegate. Her publications include, among others, as lead author in several scientific articles published in peer-reviewed international journals (few accepted without correction) covering pharmaceutical science, chemometrics (i.e. factorial designs, central composite designs) and liquid chromatography.

Margareth Ndomondo-Sigonda

Margareth Ndomondo-Sigonda

BPharm, MSc, MBA, PhD

African Union Development Agency (AUDA-NEPAD) Head of Health Program

Heads Health Program at AUDA-NEPAD since September 2016, before that served as Pharmaceutical Coordinator since March 2010. Responsible for coordination and providing oversight on health programs including TB and Occupational Health and Safety, Integrated Vector Management (IVM), the African Medicines Regulatory Harmonization (AMRH) Initiative, the establishment of African Medicines Agency (AMA) and promotion of local production of medical products as part of the African Union Health Strategy (2016-2030) and Pharmaceutical Manufacturing Plan for Africa (PMPA) policy frameworks. Served as Chief Pharmacist (1998), Registrar of Pharmacy Board (1998-2003) and the first Director General of the Tanzania Food and Drugs Authority (2003-2010) under the Ministry of Health and Social Welfare, Tanzania.

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