為不斷提高中國(guó)醫(yī)藥行業(yè)質(zhì)量體系，更好地服務(wù)于全球患者的需求搭建平臺(tái)，使中國(guó)業(yè)界能夠更好地了解國(guó)際監(jiān)管要求，為中國(guó)企業(yè)以多種形式參與國(guó)際化發(fā)展提供強(qiáng)有力的支持，中國(guó)醫(yī)藥保健品進(jìn)出口商會(huì)將于2021年12月15日14:00-17:00以線上會(huì)議形式舉辦2021CPhI國(guó)際藥政答疑會(huì)（法規(guī)更新專題）。

       藥典標(biāo)準(zhǔn)有哪些變化？監(jiān)管機(jī)構(gòu)的最新關(guān)注是什么？疫情下的現(xiàn)場(chǎng)檢查如何開展？除化學(xué)制劑之外，在原料藥、輔料、包材和在生物藥方面，國(guó)際機(jī)構(gòu)有哪些關(guān)注？藥政官員和行業(yè)專家將一一為企業(yè)做解答。

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       僅限CPhI&P-MEC中國(guó)展展商參加

       法規(guī)更新專題

       12月15日重磅嘉賓

       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

       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

       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

       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

       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

       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

       陳葭

       醫(yī)保商會(huì)外聯(lián)協(xié)調(diào)員

       會(huì)議日程

       法規(guī)更新專題

       12月15日 14:00-17:00

       14:00-14:30

       FDA監(jiān)管法規(guī)更新

       FDA Regulatory Updates

       美國(guó)食品藥品管理局 中國(guó)辦公室代理助理主任 程志禮博士

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

       14:30-15:00

       歐洲藥品質(zhì)量管理局關(guān)于CEP程序的更新

       Update on the EDQM CEP procedure

       歐洲藥品質(zhì)量管理局

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

       15:00-15:30

       世衛(wèi)組織預(yù)認(rèn)證藥品項(xiàng)目的更新

       Updates on prequalification of medicines programme

       世衛(wèi)組織 藥品預(yù)認(rèn)證項(xiàng)目 藥品質(zhì)量審評(píng)員 尹華

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

       15:30-16:00

       加強(qiáng)英國(guó)臨床試驗(yàn)的監(jiān)管環(huán)境

       Enhancing the UK regulatory environment for clinical trials

       英國(guó)藥品和健康產(chǎn)品管理局 臨床實(shí)驗(yàn)部門負(fù)責(zé)人

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

       16:00-16:30

       菲律賓藥品法規(guī)更新

       Philippine Regulatory Updates

       菲律賓藥監(jiān)局藥品監(jiān)管和研究中心高級(jí)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

       非洲聯(lián)盟發(fā)展機(jī)構(gòu)在非洲藥監(jiān)局籌備中的角色

       The role of AUDA-NEPAD in the operationalisation of AMA

       非盟發(fā)展署衛(wèi)生項(xiàng)目負(fù)責(zé)人 瑪格麗特·恩多蒙多·西貢達(dá)

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

       報(bào)名方式

       掃描或長(zhǎng)按識(shí)別二維碼報(bào)名

       會(huì)議免費(fèi)，報(bào)名需審核

       僅限CPhI&P-MEC中國(guó)展展商參加

       會(huì)議聯(lián)系人

       陳葭、潘越

       電話：010-58036223/6327

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

       會(huì)議預(yù)告

       1

       12月16日 14:00-16:30

       原料、輔料、包材專題

       2

       12月17日 14:00-16:00

       生物藥專題

       展位與廣告咨詢

       茅女士 Chris Mao

       電話：021-33392250

       郵箱：chris.mao@imsinoexpo.com

       吳女士 Sharon Wu

       電話：010-58036296

       郵箱：wuyushuang@cccmhpie.org.cn

       參觀與媒體咨詢

       施女士 Zoe.shi

       電話：021-33392447

       郵箱：Zoe.shi@imsinoexpo.com

       劉女士 Vicky Liu

       電話：010-58036334

       郵箱：liuweiqi@cccmhpie.org.cn