In 2015, South Korea introduced legislation designed to protect human health and the environment from the impact of chemicals. With an estimated 44,000 chemicals in use in South Korea and about 300 new chemicals marketed annually, registrants and regulators will be kept busy assessing the risk posed to humans, animals and the environment. This legislation was revised to impose stricter controls on a broader range of substances, effective January 1, 2019.
Continue readingNavigating COVID-19: The Importance of a Nimble Reimbursement Call Center Operation
The impact of COVID-19 on reimbursement call center operations has the potential to be significant. However, a proactive crisis management plan and a dispersed, redundant operating model can go a long way towards safeguarding your patient support programs. As governments and citizens address challenges posed by this global pandemic, many companies are limiting in-office operations, or closing them entirely. Now is a good time to evaluate your current and future reimbursement call center strategy and be as prepared as possible for the unexpected events that interrupt patient access to your therapies.
Continue readingAre You the 33 Percent? The National Kidney Foundation wants to know, and help
They are not something most of us think about, that is, until something goes wrong. They filter 53 gallons of blood per day, remove toxins and excess volume from your blood, and help control other things like blood pressure and hemoglobin counts. They are our kidneys: two fist-sized bean-shaped organs that keep you healthy by making sure your blood remains in metabolic balance. Once a patient approaches kidney failure, we hope to get them a kidney transplant, but the reality is that the majority of patients undergo dialysis simply because there are not enough donated kidneys to go around. Either dialysis or a kidney transplant is needed to survive once kidney function is so poor that it needs replacement therapy.
Continue readingHow 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? Find out here.
Continue readingAre You Ready? Impact of Upcoming Regulatory Requirements on Combination Product Reporting
Combination Products: What are they?
Any product formed from the combination of a drug, a device and a biologic is referred to as a combination product. Under 21 CFR 3.2 (e) this includes two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity.
Continue readingAdvancing Innovations in Early Stage Oncology Research: Meet Amy
Many novel oncology treatments have brought new hope to people living with cancer, but these breakthrough medicines weren’t developed overnight. On average, it takes at least 10 years to create a treatment “from molecule to medicine.”
As a Study Director at Covance, Amy supports a key part of this process by helping pharmaceutical and biotech companies thoroughly evaluate their oncology drug candidates at the early stages.
Continue readingRare Diseases Are Not So Rare
Some have famous fundraising events attached to them, like the Ice Bucket Challenge for ALS or the many walks, runs, and telethons for diseases ranging from Cystic Fibrosis to Muscular Dystrophy. Other conditions, like Wilson’s Disease – a rare condition in which excess copper builds up in the body — are virtually unknown except to the friends and family of those living with the disease. Collectively, there are 7,000 distinct rare diseases, which, according to the advocacy group Global Genes, affect up to 400 million people globally. About half of those diagnosed with a rare disease are children.
Continue readingHow 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.
Continue readingHonoring African American History Month: Recognizing Contributions from One of Our Own Community-Builders
National African American/Black History Month recognizes the accomplishments of African Americans who have made a difference in our society. Many notable African American physicians, engineers, scientists, and nurses have contributed to medical and scientific breakthroughs and continue to serve as role models for students of color interested in pursuing careers in the STEM (science, technology, engineering and mathematics) fields.
Continue readingExpediting SEND Datasets for an International Regulatory Submission
A case study with Peg Biomedical Co., Ltd
Peg Biomedical Co., Ltd. (Peg Bio), is a Suzhou, China-based biopharmaceutical company specialized in developing innovative medicines for metabolic diseases including type 2 diabetes, obesity, and non-alcoholic hepatitis.
While business between Peg Bio and Covance first started in 2014, the strength and depth of our relationship was highlighted in Spring 2019. In May that year, more than 400 Covance employees relocated to a new facility – the Aland Center in Zhangjiang Hi-Tech Park of Shanghai’s Pudong District- and Dr. Michael Xu, CEO of Peg Bio, was invited to deliver a speech for the new site opening ceremony. In his address, Dr. Xu expressed his gratitude for Covance’s service delivery, “among all of the collaborators, Covance is probably the best time‑keeping CRO we have worked with.”
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