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Thursday, June 29 • 8:30am - 9:30am
#405: CIOMS: What it Does and the Guideline on Patient Involvement in the Development, Regulation, and Safe Use of Medicines

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-659-L04-P; CME 1.00; RN 1.00

CIOMS was established by WHO and UNESCO in 1949 and brings together national academies of sciences, regulators, industry, patient organizations, and academics to develop guidelines on a wide range of pharmacovigilance, bioethics, and drug development. These guidelines are quietly influential- people may not realize that the original form for reporting adverse drug reactions to regulatory authorities was developed by CIOMS. The most recently published guideline is on “Patient involvement in the development, regulation, and safe use of medicines” and makes recommendations on how to involve patients as partners throughout the lifecycle of a medicine.

In this session, we will provide an overview of the work of CIOMS, discuss briefly the latest guideline followed by a moderated panel discussion including polling, questions, and answers from the audience.

Learning Objectives

Describe what CIOMS is and does; Discuss how to have patients as partners in the development, regulation, and safe use of medicines; Discuss the opportunities and barriers to implementing this in your own organization.

Chair

Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP

Speaker

EMA Update
Juan Garcia-Burgos, MD, PhD

CIOMS Update
Hervé Le Louet, DrMed, DrSc, MD, PhD, MS

Patient Perspective
Aleksandra Maria Leijenhorst


Speakers
avatar for Stella Blackburn

Stella Blackburn

Strategy, Consultant, United Kingdom
Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTM, Stella studied medicine at Cambridge and Guys, working in hospital medicine before joining the pharma industry. She has worked in PhV and pharmacoepi for 35 years: in industry (11+ years) as a regulator (16+ years... Read More →
avatar for Juan Garcia-Burgos

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation... Read More →
avatar for Aleksandra Leijenhorst

Aleksandra Leijenhorst

Coordinator for the LGMD CAB; Chair of Stichting SpierKracht & DITA Taskforce Me, Eurordis, Netherlands
I'm Aleksandra Leijenhorst-Le Belle, 56, mom of 4 kids. My eldest passed away because of HLHS and my two youngest have a rare type of muscular dystrophy. Originally I was social care worker at the department of Justice but I chose to quit and enjoy every moment with my kids. I am... Read More →
avatar for Hervé Le Louet

Hervé Le Louet

President, CIOMS, Switzerland
Hervé is an Hepatologist, professor of clinical pharmacology and former head of the vigilance department of the Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), including the Pharmacovigilance unit, the Hemovigilance/ Biovigilance unit and the infection... Read More →

Thursday June 29, 2023 8:30am - 9:30am EDT
Room 205 A Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  05: Patient Engagement, Session |   01: ClinSafety-PV, Session