Sunday, December 1
is World AIDS Day, an international day dedicated to raising awareness of the
AIDS pandemic caused by the spread of HIV infection, and a time to remember
those who have died of the disease. It has been observed worldwide since 1988.
Oren Cohen, MD,
Covance Chief Medical Officer, was an infectious disease physician in New York
City during the early days of the epidemic and shares this remembrance:
Residues of plant protection products (PPPs) are inevitably present in or on food, even when they are applied in line with good agricultural practice. The upper limit of residue permitted on food or feed is the ‘maximum residue level’ (MRL), which, in Europe, is legislated by the European Commission based on scientific advice from the (EFSA).
MRLs are measured via crop residue field trials, which replicate the real-life agricultural conditions under which a PPP would be used. It sounds a simple enough procedure, but what studies are commonly used and what are the secrets to success?
Successfully demonstrating product safety and efficacy in a randomized clinical trial is a monumental event, but it doesn’t always translate to market access and uptake one it’s launched. Since clinical trials are limited to a controlled sub-set of patients, observations recorded in the clinical trial setting can vary from what actually occurs in clinical practice. That’s where real-world evidence (RWE) can help pharmaceutical companies to inform development planning and also to demonstrate a product’s comparative effectiveness, safety and value from the viewpoints of various stakeholders, including regulators, payers, prescribers and patients.
This article discusses the role of RWE, the different information needs among stakeholders and potential solutions for meeting their evolving requirements.
Our “Meet Me in 5” series covers 5 people, topics or
questions to illustrate how our business nurtures exceptional people, provides
an energizing purpose and enables extraordinary potential in its employees’
In this article, we spoke to Ilse Mathieu, Site Lead
European Operations Center – Associate Director, EMEA Distribution, based in Mechelen,
Belgium. She discussed how the Covance Mechelen site is ramping up to become a major
kit production facility to supply clinical trial kits across Europe, the Middle
East and Africa – and what this high-profile project means for career growth
opportunities in Mechelen.
The New EU Nanotechnology Regulation
On December 3, 2018, the European Commission (EC) adopted Regulation 2018/1881, amending the existing Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, to directly address nanoparticles. The nanotechnology regulation applies to any substance that might be, or might contain, a nanomaterial (e.g., powder), whether or not it has been manufactured as a nanotechnology. Crucially the revised nanoparticle regulation applies to both new and registered substances and all dossiers will need to be updated with the necessary data.