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.
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).
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.
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.
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.
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.
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
Update on the EDQM CEPprocedure
Hélène Bruguera, Head of the Certification Department, European Directorate for QualityMedicines
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
加强英国临床试验的监管环境 Enhancing the UK regulatory environment for clinical trials
Dr. Martin O'Kane, Head of the Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency (MHRA)
非洲联盟发展机构-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
Dr Margareth Ndomondo-Sigonda, Head of Heath Unit, AUDA-NEPAD
菲律宾药品法规更新 Philippine Regulatory Updates
Jesusa Joyce N. Cirunay, Director IV of the Center for Drug Regulation and Research, The Food and Drug Administration Philippines
Dr. Ulrich Rose
Head of Division A
Deputy Head of the European Pharmacopoeia Department
Dr Ulrich Rose is pharmacist by training and obtained his PhD in pharmaceutical chemistry in 1985. Before joining the EDQM in 1991, he was Assistant Professor and lecturer for pharmaceutical analysis and physico-chemistry at the University of Mainz in Germany. Until 2011, he was responsible for the establishment and monitoring of European Pharmacopoeia (Ph. Eur.) reference standards in the European Pharmacopoeia laboratory. Moreover, he was involved in the elaboration and revision of Ph. Eur. monographs. After that, he became co-ordinator and auditor for the EDQM’s Mutual Joint Audit programme. Within this function, he audited the Official Medicines Control Laboratories in and sometimes outside Europe. Since 2014, he is Head of Division A and Deputy Head of the European Pharmacopoeia Department where he is overlooking the monograph work on chemically defined active substances, herbals, finished products and general chapters and is involved in the international harmonisation of pharmacopoeias。
毕业于山东大学药学院，获天然药物化学博士学位，2009-2010年在美国Virginia Commonwealth University 从事博士后研究工作，2018年在美国药典委员会从事访问科学家（visiting scientist）工作。2002-2019 年在药检系统从事化学药品和药用辅料的质量控制和标准制修订工作，致力小分子化学药和药用辅料的质量研究与控制，以及药典间的国际合作和交流。
Shine Gao, Chairman of Quality Subcommittee of IPEC China
Assistant Country Director, FDA China Office
Tonia Bernard is an Assistant Country Director with the FDA’s OGPS China office, where she performs inspections of pharmaceutical facilities located in China. Prior to joining the FDA China Office, Ms. Bernard has more than 5 years of field experience with FDA’s ORA performing a broad range of domestic and foreign drug inspections. She earned a Master of Public Health in Environmental Science from Fort Valley State University in Fort Valley, Georgia and a Bachelor of Science in Exercise Science from University of Maryland Eastern Shore in Princess Anne, Maryland.