You Brexit, You Buy It – Europe and the New Regulatory – Part 1 of 2 By Lynn Hansen, Director of Clinical and Regulatory Affairs, Pharmatech Associates With Brexit looming, questions and concerns hover like a grey cloud over the UK pharmaceutical industry. Industry insiders and colleagues in London found that the confusion surrounding what…
Hurry Up and Wait: Brexit from a Regulatory Point of View – Part 2
You Brexit, You Buy It – Europe and the New Regulatory – Part 2 By Lynn Hansen, Director of Clinical and Regulatory Affairs, Pharmatech Associates In Brexit Part 1, I expressed my Brexit thoughts as Theresa May was providing a tearful resignation and now the United Kingdom has the return of an energetic Boris Johnson,…
Jump into cGMP: An FDA Roadmap to Manufacturing Tissue-based Products
Companies currently in the tissue-based regenerative medicine business need to understand and comply with the FDA’s expectations for human cells, tissues and cellular and tissue-based product (HCT/P) under development in the next two years. HCT/P pertains to products containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. If we are to jump…
Regulatory Experience Plays into New Regulatory Affairs Certifications for 2019
With new exams introduced this year, the Regulatory Affairs Certification (RAC) program has seen major changes since the beginning of 2019, as announced at the Regulatory Affairs Professional Society (RAPS) Regulatory Annual Convergence meeting in October 2018. There are two new Regulatory Affairs Certifications with the associated exams for RAC (Drugs) and RAC (Devices). These…
ERP Verification and Validation in a Highly Regulated Environment
The U.S. Food and Drug Administration has created a complex regulatory regimen to ensure the safety of products offered to consumers. It also helps mitigate the risk for manufacturers by mandating that they adhere to these stringent requirements. Making the Right Choice The enterprise software selected for manufacturing medical devices and pharmaceutical products is of…
Pharma Execs Face the Feds
The leaders of seven major pharmaceutical companies have been called to testify before the Senate Finance Committee, on the topic of drug prices. The committee is led by Senators Chuck Grassley of Iowa and Ron Wyden of Oregon, who argue that prescription drug costs have climbed too high and the rate at which prices are…
