The Latest Acorn Regulatory Newsletter

August 2020

The August 2020 edition of the newsletter looks at the ‘hot topic’ of orphan drugs.  Our Medical Manager, Dr. Danica Cvetkovic, looks at the issue in this edition of the newsletter.

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Pharmacovigilance of Medicines for Rare Diseases

Dr. Danica Cvetkovic looks at the issue of pharmacovigilance for orphan or rare diseases.  Many issues associated with the sector are challenged by the small patient population. This article looks at the commonly used strategies for evaluation of post-approval safety and the effectiveness of rare and orphan drugs.

Read the article here.

 

Veterinary Clinical Trials: New EU Law & Global Approaches

Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a veterinary clinical study involves research that gains information from animal patients.

Read more here

Moving from MDD to MDR?  Here Is What You Need To Know

MDR will come in to force in 2021.  It differs greatly from the MDD.  What will the major changes be for medical devices manufacturers, importers, and distributors? We look at the major changes in the move from MDD to MDR in this article.

Read more here

Download our CMC E-Book

Acorn Regulatory’s team of CMC, pharmacovigilance, quality, clinical and medical devices experts consistently produce articles for the sector.  In the CMC e-book we have compiled some of the most-read articles into a downloadable PDF.

Download the e-book now

CMC & Pharmaceutical Regulatory Affairs Services

Our pharmaceutical regulatory affairs team is staffed by experts who have considerable expertise in the sector.  Every team member has at least 15 years of  experience in the pharmaceutical sector assisting pharmaceutical companies with their regulatory issues.  Since 2002, our pharmaceutical regulatory affairs specialists have been working with clients all over the world.

Read more here.

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