Drug Safety Europe 2016

Ensuring Compliance for Cloud: A Risk Management Guide for Life Sciences Organizations

In an effort to manage cost pressures, optimize operational efficiencies, and build robust IT capabilities, the life sciences industry is also shifting to the cloud. However, being a highly regulated industry, players face significant compliance challenges while leveraging the cloud. In addition to managing security risks in a shared computing environment, organizations also need to ensure that regulatory commitments are …

Q2 2016 Cloud

Q2 Pharmacovigilance and Drug Safety Conferences – What did you miss?

Q2 Pharmacovigilance and Drug Safety Conferences – What did you miss? Great industry conferences are often the result of a combination of factors: good planning, strong speakers, with real depth in expertise and a passion for their topic, and attendees/delegates with great questions.  When all three line up in one event, all participants gain tremendous value from the presentations and …

genomeweb whitepaper

Alternative Proposals for Lab Test Regulation

Are There Opportunities for Consensus? A GenomeWeb Report February 2016 Amid multiple proposals on LDT regulation, are there opportunities for consensus? By Turna Ray The lab industry entered 2016 in a staring contest with the US Food and Drug Administration that began two years ago when the agency released its draft guidance on regulating laboratory-developed tests (LDTs). During the course …

Ebook: Your essential guide on trends, regulations and new technologies in Drug Safety

Drug safety must continue to evolve to meet heightened patient expectations and the fluctuating regulatory climate. It is becoming critical to exploit opportunities offered by emerging technologies, big data and personalised healthcare. To succeed in this new environment, we need to assess the regulatory updates; we need to examine how to implement regulations strategically and operationally in addition to discussing …

Embracing big data and emerging technologies in drug safety

Which new approaches are pharma companies taking to exploit opportunities offered by big data? We’ll be answering this question and many more as we discuss big data and related innovative technologies at World Drug Safety Congress Europe. Hear from a plethora of thought leaders who will be sharing real life examples of how to develop big data programmes and social media …

Addressing the key challenges for drug safety professionals

The regulatory environment is fast changing and the drug safety industry is facing significant hurdles in implementing standards globally. It is becoming increasingly challenging to meet all regulatory requirements effectively in the current globalised marketplace. Stay on top of pharmacovigilance requirements with updates directly from the regulators, agencies and industry who will show you how to implement regulatory standards globally. Learn …

pharma, pharma pricing, market access, drug, considerations, pharma pricing and market access europe

Ebook: Key Considerations for Market Access

In an era of austerity and rising health care costs, payers are exerting greater influence over pharmaceutical markets and demanding insight into a drug’s value and cost effectiveness. Creating an effective market access strategy is vital for a successful product launch. You need to integrate the payer perspective throughout the development and decisions making process. In this ebook, we share …

Could Antibodies Provide the Answer to Curing Ebola?

Newly discovered antibody drugs such as ZMAPP could provide a solution to the Ebola epidemic that’s sweeping across the globe. We have known about the capacity of antibodies for modulating the immune system for decades, and there are already hundreds of antibody-based drugs that are used to effectively fight various illnesses such as cancer and autoimmune diseases. ZMAPP has been shown …

Sanofi files cases against Glenmark on patent infringement

Sanofi filed a patent infringement petition against Glenmark on their cardiac drug Multaq in the district court of Delaware. They filed the suit against Glenmark and Actavis wanting to prevent them from commercializing its ANDA productprior to the expiration of certain US patents. Multaq is an anti-arrhythmic drug that reduces the risk of hospitalisation for atrial fibrillation (AF) in patients …

Ovarian cancer biomarker could predict treatment response and help prevent metastasis

A research team from Case Western Reserve University in Ohio discovered a new microRNA biomarker, miR-181a, that may identify patients who will respond better to treatment for ovarian cancer and could serve as a drug target to prevent metastasis. Ovarian tumors are more likely to be resistant to chemotherapy with high levels of miR-181a, which in turn promotes metastasis by …