Download: From Safety Governance to Benefit Risk Governance

At last year’s World Drug Safety Congress Europe, Peter Verdru, MD, Safety Sciences, UCB gave a presentation on “From Safety Governance to Benefit Risk Governance.” Verdru mentions that the continuous safety profile monitoring and benefit risk evaluation of authorised medicinal products is critical to pharmacovigilance processes.  He goes on to discuss in depth, Benefit Risk Teams, Benefit Risk membership, Benefit Risk board …

GPCB issues closure notice to Zydus Cadila research unit

Gujarat Pollution Control Board (GPCB) has issues a closure notice to Zydus Cadila’s research unit in Ahmedabad for allegedly polluting ground water. They received a complaint from people that their unit at Moraiya area has been discharging polluted effluents to ground water. Upon receiving the complaints, GPCB officials inspected the area and found the irregularities, violating provisions of the Prevention …

US FDA Commissioner Margaret Hamburg met with Indian health regulators and pharma execs, saying she wanted to see more collaboration between FDA and Indian officials. However, India’s top drug regulator, G.N. Singh, the Drug Controller General of India, feels a little reluctant about adhering to all of FDA’s standards and expectations. He says that he sees some areas where the …

Sciformix Whitepaper: Safety and Risk Management

  The area of safety signal detection has come into focus over the past few years and is growing in importance. It is well accepted that statistical methods of signal detection can flag certain drug-event combinations for in-depth analysis from a medical perspective, potentially leading to confirmation of evidence and identification of a signal. It is recognized that the quality of the data on which these methods are …

Download: Drug Safety Outlook- Predictions and analysis of drug safety today and tomorrow

The drug safety sector is in a transition phase, progressing from a reactive to a more proactive mind-set. Change in the industry such as the new benefit risk standards, regulatory environment, safety informatic innovations and signal management processes, are all helping to help drive patient safety on the global scale. This is a critical change that will prioritise the patient, …

Indian Pharma: Biocon’s Herceptin biosimilar & the uncertain future

Mylan-Biocon: trastuzumab biosimilar On Monday it was announced that Biocon had received approval from the Drug Controller of India for the first biosimilar to Roche’s widely used HER2 breast cancer drug, Herceptin. Biocon and partner Mylan’s trastuzumab product, one of five biologics in development between the Indian company and the American giant, will be sold under the name of Hetraz. …

Download: Whitepaper ‘Ensuring risk free pharmacovigilance’

Sciformix is a knowledge based global service provider for the Pharmaceutical and Biopharmaceutical industry. They partner with their clients through the entire drug development cycle, to provide a full range of services from study design to post marketing surveillance and commercialization support. Areas of specialization include Safety and Risk Management, Biometrics, Scientific Writing, and Regulatory Affairs. The increase in the …