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This book has 12 chapters covering nearly all the areas of Drug Regulatory Affairs. Various aspects of Drug Regulatory Affairs such as new drug approval procedure, pharmacovigilance, product recall, evolution of drug regulations in the United States of America (USA) and process of drug approval in the USA and European Union, bioequivalence regulations, electronic Common Technical Documents (eCTD), environmental regulations, orphan drugs pharmaceutical pricing and control policy, Pharmacovigilance system in India and the USA, Product Recall, regulations of pharmaceutical drug promotion and Pharmacy Practice regulations are covered in this book. As a whole, the book is a comprehensive reference book on regulatory affairs and will be very useful for the practicing professionals and students alike.

Author: Melita Sheilini

This book has been written keeping in mind the technological advancements in the field of health care and the services that are demanded by the critical care staff nurses, who indeed one of the front line care givers in the critical care units. In this rapidly changing world, there are many challenges for a critical care nurse as the needs, expectations of the society are increasing, and the nursing care is moved towards the family oriented model from the traditional patient oriented model. A prudent critical care nurse needs to be competent in taking care of the patients. As a vital member of the health care team, the nurse is expected to be responsible and accountable for the outcome of the patient under her/his care.

Interested readers may write to us at mup@manipal.edu about purchasing the book.

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