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2021CPhI国际药政答疑会(法规更新专题)

https://www.cphi.cn   2021-12-15 09:52 来源:CPhI世界制药原料中国展

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

       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)。

       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.

       主持人

      陈葭

       陈葭

       医保商会外联协调员

       会议日程

       法规更新专题

       12月15日 14:00-17:00

       14:00-14:30

       FDA监管法规更新

       FDA Regulatory Updates

       美国食品药品管理局 中国办公室代理助理主任 程志礼博士

       Dr. Juliette Taylor, Acting Assistant Country Director of FDA China Office, Food and Drug Administration

       14:30-15:00

       欧洲药品质量管理局关于CEP程序的更新

       Update on the EDQM CEP procedure

       欧洲药品质量管理局

       Hélène Bruguera, Head of the Certification Department, European Directorate for QualityMedicines

       15:00-15:30

       世卫组织预认证药品项目的更新

       Updates on prequalification of medicines programme

       世卫组织 药品预认证项目 药品质量审评员 尹华

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

       15:30-16:00

       加强英国临床试验的监管环境

       Enhancing the UK regulatory environment for clinical trials

       英国药品和健康产品管理局 临床实验部门负责人

       Dr. Martin O'Kane, Head of the Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency (MHRA)

       16:00-16:30

       菲律宾药品法规更新

       Philippine Regulatory Updates

       菲律宾药监局药品监管和研究中心高级主任

       Jesusa Joyce N. Cirunay, Director IV of the Center for Drug Regulation and Research, The Food and Drug Administration Philippines

       16:30-17:00

       非洲联盟发展机构在非洲药监局筹备中的角色

       The role of AUDA-NEPAD in the operationalisation of AMA

       非盟发展署卫生项目负责人 玛格丽特·恩多蒙多·西贡达

       Dr Margareth Ndomondo-Sigonda, Head of Heath Unit, AUDA-NEPAD

       报名方式

       扫描或长按识别二维码报名

       会议免费,报名需审核

       仅限CPhI&P-MEC中国展展商参加

 二维码

       会议联系人

       陈葭、潘越

       电话:010-58036223/6327

       邮箱:ceec@cccmhpie.org.cn/ panyue@cccmphie.org.cn

       会议预告

       1

       12月16日 14:00-16:30

       原料、辅料、包材专题

       2

       12月17日 14:00-16:00

       生物药专题

       展位与广告咨询

       茅女士 Chris Mao

       电话:021-33392250

       邮箱:chris.mao@imsinoexpo.com

       吴女士 Sharon Wu

       电话:010-58036296

       邮箱:wuyushuang@cccmhpie.org.cn

       参观与媒体咨询

       施女士 Zoe.shi

       电话:021-33392447

       邮箱:Zoe.shi@imsinoexpo.com

       刘女士 Vicky Liu

       电话:010-58036334

       邮箱:liuweiqi@cccmhpie.org.cn

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