drug safety
Keeping tabs on Covid-19: UK approves safety of Pfizer and BioNTech’s Covid-19 vaccine
December 04 by Emily UwemedimoA breakthrough and scientific achievement for Pfizer and BioNTech as they receive the green light from UK regulators to help in the fight to end the pandemic
10 Top Tips for Effective Pharmacovigilance
October 02 by Pharmaceuticals & Biotechnology EditorThere are several challenges around pharmacovigilance in Asia and perspectives are different for industry, regulatory authorities, academia and healthcare professionals. Ahead of the 5th Annual Phar...
Reflections on the Biomanufacturing Summit and how the Major Topics Apply in the US- Douglas Ball
May 07 by Niamh MadiganDouglas Ball, Research Fellow at Pfizer, Inc. reflects on the major issues raised at the Disposable Solutions for Biomanufacturing conference in Belgium such as best manufacturing practice and regul...
Minimizing the Regulatory Ripple Effect for Quality and Training in Drug Safety Organizations
September 10 by Amber ScorahEven a slight change to a regulation can have a huge effect throughout an organization. Given the recent overhaul of the EMA drug safety requirements, the ‘ripple effect’ is more like a...
Saudi FDA: Working with Industry to Improve the Reporting of Adverse Reactions
December 13 by Andrea CharlesIn this interview Dr. Nasser Al-Qahtani, Head, Adverse Drug Reactions Evaluation Department Saudi FDA speaks to Andrea Charles from Pharma IQ, about the Saudi FDA pharmacovigilance system and wha...
Drug Safety Management in Japan: An Update on Current and Future Regulations
August 11 by Pharma IQJapan's pharmaceutical market is the second largest in the world but has long suffered from the so-called drug lag. Lengthy approval processes for drugs have seen medicines readily available...
Pharmacoepidemiology and Pharmacovigilance
July 04 by Elie MagdalaniPharmacology is the study of the effects of drugs. The other interesting branch known as the “clinical pharmacology” is interested in the effects of drugs in humans by which therapy is individualised...
Medication Errors - A Shared Responsibility
June 03 by Elie MagdalaniWhat is a medication error? The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) defines a "medication error" as follows: "A medication error i...
PPD takes Pharmacovigilance to Bulgaria
May 19 by Pharma IQMany companies that specialise in pharmacovigilance have sprung up in recent years. In addition, a number of others have enjoyed major growth. One firm that falls into the latter catego...
Can New Media Improve the Output of Pharmacovigilance Data?
May 13 by Shaloo PandhiShaloo Pandhi, Group Head of Pharmacovigilance Operation at Novartis Healthcare, shares his insights on pharmacovigilance in India. Pharma IQ: There is an immense need to address...
Global Drug Safety and Risk Management
May 06 by Elie MagdalaniReported adverse events are an important tool for implementing a risk management program. An important contributing factor in the evolved AEs the condition of chronically ill patients taking a drug da...
Using New Media to Improve the Output of Pharmacovigilance Data
April 05 by Andrea CharlesShaloo Pandhi, Group Head Pharmacovigilance Operation, Novartis Healthcare, India, talks to Andrea Charles from Pharma IQ, about risk management strategies and optimising drug safety activities...