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European Medicines Agency

2018年10月25日 (木) 午前 8:00 - 2018年10月25日 (木) 午後 4:30

30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom

EMA Information Day on Risk Management Planning

GVP GUIDELINES ON SPECIAL POPULATIONS

Session Chair(s)

Priya  Bahri, PhD, RPh

Priya Bahri, PhD, RPh

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)

European Medicines Agency, Netherlands

Pharmacovigilance guidelines (GVP) in special populations, i.e. children, older patients and women concerning pregnancy and breastfeeding, are currently being developed. The RMP Info Day will offer the opportunity to share the current status of the guidelines with a special emphasis on the impact of new guidelines on medicines risk management in these populations. Furthermore, this will be an opportunity to solicit input from stakeholders for further development specifically of the GVP on older people to enhance medicines’ safety in the geriatric population.

Speaker(s)

Roberto  De Lisa, MD

GVP for Paediatrics

Roberto De Lisa, MD

European Medicines Agency, Netherlands

Scientific Officer, Paediatric Medicines Office

Priya  Bahri, PhD, RPh

GVP for Older People

Priya Bahri, PhD, RPh

European Medicines Agency, Netherlands

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)

Corinne  de Vries, PhD, MA, MSc

GVP for Pregnancy

Corinne de Vries, PhD, MA, MSc

European Medicines Agency, Netherlands

EMA liaison official to the US FDA

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