2021CPhI國際藥政答疑會（法規(guī)更新專題）

熱門推薦： CPHI國際藥政答疑會 , 國際監(jiān)管要求 , 法規(guī)更新專題 ,

來源：CPhI世界制藥原料中國展

2021-12-15

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

2021CPhI國際藥政答疑會

藥典標準有哪些變化？監(jiān)管機構的最新關注是什么？疫情下的現(xiàn)場檢查如何開展？除化學制劑之外，在原料藥、輔料、包材和在生物藥方面，國際機構有哪些關注？藥政官員和行業(yè)專家將一一為企業(yè)做解答。

會議免費，報名需審核

僅限CPhI&P-MEC中國展展商參加

法規(guī)更新專題

12月15日重磅嘉賓

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

?陳葭