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EMA Yearly Update on MLM – highlights and next steps

Posted on January 19th, 2016 by

Pharmacovigilance

pills

EMA  Pharmacovigilance Programme Update Issue 6 – Preparing for Business Change

Since July 2014, EMA provides quarterly Pharmacovigilance Programme Updates to Marketing Authorisation Holders (MAHs). Continue reading “EMA Yearly Update on MLM – highlights and next steps” »

Unmixing the messages

Posted on January 18th, 2016 by

Pharma R&D

R_D_Solutions_Blog_Image_Cars_DIGITAL

Have you ever driven through a red light because you were looking at the wrong traffic signal? Or had a row of angry motorists behind you because you hadn’t realized the signal above your lane had turned green? Continue reading “Unmixing the messages” »

Monitoring literature for Benefit-Risk Evaluation: a Life-Time Responsibility

Posted on January 15th, 2016 by

Pharmacovigilance

Medical Literature

Monitoring worldwide experience

The purpose of drugs is to cure or alleviate symptoms of disease. However, drugs do not only have therapeutic effects, they may also cause adverse drug reactions (ADRs). Continue reading “Monitoring literature for Benefit-Risk Evaluation: a Life-Time Responsibility” »

Does improving pre-clinical research reduce late-stage failures and improve R&D productivity?

Posted on January 12th, 2016 by

Pharma R&D

R_D_Solutions_blog_image_male_female_researchers_DIGITAL

It’s the turn of the year and if you’re like me, you’ve been immersed in reading all of the accompanying look back and look ahead articles and reports. 2015 was, indeed, a notable year — from the Martin Shkreli fiasco to the proposed Pfizer and Allergan merger — the industry was rocked. Continue reading “Does improving pre-clinical research reduce late-stage failures and improve R&D productivity?” »

Could a Change in R&D Focus Lead to a Reinvented Pharma?

Posted on January 8th, 2016 by

Pharma R&D

reinvention

In early December, the New York Pharma Forum held its 26th Annual General Assembly, focusing on the theme “The Reinvention of Pharma,” and featuring executive-level speakers from Pfizer, Sunovion, Takeda, The Japan Pharmaceutical Manufacturers Association and the consulting company Defined Health to expound upon this theme. Continue reading “Could a Change in R&D Focus Lead to a Reinvented Pharma?” »

Pharmacovigilance events in different regions cover common concerns

Posted on January 7th, 2016 by

Pharmacovigilance

IMG_0068

In December, Elsevier sponsored the 11th Annual Pharmacovigilance, Drug Safety and Risk Management conference in Brussels, Belgium and the 2nd Adverse Event Reporting and Safety Strategies Summit in Philadelphia, USA.  Continue reading “Pharmacovigilance events in different regions cover common concerns” »

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About this Blog

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The Elsevier Pharma R&D blog provides insight and opinion on topics related to pharmaceutical research and development, namely: big data, target identification, new drug discovery, drug safety monitoring, risk mitigation and regulatory compliance. We serve the community of chemists, scientists, drug safety specialists, educators and students interested in pharmaceutical R&D.

Editor’s note: The views and opinions expressed are those of the author and do not necessarily reflect the views of Elsevier,  its affiliates and sponsors or its parent company, Reed Elsevier.