Studies on Pharmacovigilance in Bangladesh

ISBN-13: 9783659382598 / Angielski / Miękka / 2013 / 60 str.

Saha Dibyajyoti;Paul Swati

Opis

An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the block by various stakeholders, more importantly by the regulatory authorities. The number of adverse drug reactions (ADRs) reported, have also resulted in an increase in the volume of data handled. To understand pharmacovigilance a high level of capability is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Positive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety.It is a challenge to arrange and regiment the act of signal detection and risk management in the context of clinical trials and post- marketing pharmacovigilance. With more clinical trials and clinical research activity being conducted in Bangladesh, there is an immense need to understand and implement pharmacovigilance.This book describes and discusses the various strategies and proposals to build, maintain and implement a robust pharmacovigilance system for various stakeholders and eventually make it happen in Bangladesh.

O autorze

Assoc.Prof. Dr. Dibyajyoti Saha(Young Scientist),Chairman, Department of Pharmacy,BGC Trust University Bangladesh,Chittagong who was elected as an associates and fellows from various professional bodies.He has above 7 years of teaching experiences.He received D.Sc. from Colombo,Sri Lanka and more than 110 papers and 07 book publications