Closing the knowledge gap with Real-World Evidence (RWE) studies: the importance of starting early

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.

The 7 secrets to success in field trials for crop residue analysis

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).

How to renew plant protection products – EU regulations

The legislation concerning the placing of PPPs on the European single market is enshrined in Regulation (EC) No. 1107/2009, with the specific data requirements for ASs and PPPs contained in Regulations (EU) No. 283/2013 and No. 284/2013. The authorization of ASs generally expires after ten years. To enable continued marketing and sales of PPPs, a renewal of authorization of the ASs must be sought. This renewal procedure is covered by Commission implementing Regulation (EU) No. 844/2012 and is a European-level process.

Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs

Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy and safety outcomes similar to the originator biologic.1

New REACH nanomaterial requirements: what you need to do

On December 3, 2018, the European Commission (EC) adopted Regulation 2018/1881, amending the existing , 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.

Oren Cohen, MD, recalls life as an infection disease physician during the HIV epidemic of the 1980’s

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.

Addressing the challenges of data management for pharmaceutical and biotechnology companies: introducing Laboratory FSPx

Data currency management for clinical trial laboratory results can be a point of frustration for today’s pharmaceutical and biotechnology companies. Whether data is coming from a contract research organization (CRO), a central laboratory or third-party laboratories, fulfilling the need for timely availability of clean data based on unique sponsor format/industry requirements has become extremely complex.

Approaches to Accommodate a Wide Range of Asthma Patients

Controlling exposure often helps patients with asthma, a common condition that is often managed with self-care and inhalers.

How to run successful eFate studies for industrial chemicals

Environmental fate (eFate) studies are well established for crop protection chemicals and pharmaceuticals and are becoming commonplace for industrial chemicals, but what are the key considerations for setting up and running them?

Incorporating the patient voice to improve ulcerative colitis recruitment

The exact cause of ulcerative colitis (UC) is still unknown, but approximately 700,000 people in the United States suffer from this chronic, life-long disease that causes inflammation in the large intestine. A wide range of treatment options are available, but drug development sponsors are seeking additional ways to control inflammation, achieve remission and address relapses.