Tag: regulatory

Medical and Regulatory Affairs

Brexit is Pressuring Sponsors. Here’s How We’re Responding.

Months before Britons voted narrowly to leave the European Union (EU) in June 2016, then-U.K. Prime Minister David Cameron called a vote to withdraw from “the gamble of the century” and warned of dire political and economic repercussions. More than two-and-a-half years later, Cameron’s warning sounds more prescient than ever. Countless unanswered questions confront British...

Clinical Research: Phase 1 - Phase 4

Data Protection Part 1: Understanding How GDPR Affects Clinical Trials

Since it took effect May 25, 2018, the European Union’s General Data Protection Regulation has been reshaping the way data is handled across every industry sector, including clinical research. The objective of the GDPR is to strengthen and standardize the protection of personal data across the EU, including ex-EU data that is processed within the...

Medical and Regulatory Affairs

Developing Best Practices for Forging Strategic Sponsor-CRO Partnerships

Dr. Krista Armstrong, Vice President, Neuro Business Unit and Strategic Development, discusses best practices for forging strategic Sponsor-CRO partnerships. As recorded at OCT New England.

Consulting

The Engagement Gap: Bridging From Pre-clinical to First Patient In

Premier Research’s Chief Medical Officer discusses bridging the regulatory engagement gap from pre-clinical to first patient in at Outsourcing in Clinical Trials New England in Boston. Topics include: – Early regulatory engagement and creating a sound development strategy – Assessment and hiring of key staff members: which positions to fill immediately and which can wait...

Medical and Regulatory Affairs

The Evolution of Regulations for Digital Health Products

It isn’t difficult to see how technology has changed our lives for the better over the last century. From self-driving cars to smartphones, numerous innovations have made our lives safer and much more convenient. Of course, one of the most robust categories where the quality of life has improved is medicine thanks to ongoing technological...

Medical and Regulatory Affairs

Draft Guidance: Early Drug Development and the Role of Pre-IND Meetings

The FDA has released a new draft guidance for sponsors of drug and biological products for the treatment of rare diseases in early development and in the planning of and participation in formal pre-investigational new drug application (pre-IND) meetings. Read the full guidance here or click the image to download.

Medical and Regulatory Affairs

Chief Medical Officer Discussing Early Regulatory Engagement at OCT Southern California

DURHAM, N.C., November 2, 2018 — Premier Research’s Chief Medical Officer will discuss bridging the regulatory engagement gap from pre-clinical to first patient in at Outsourcing in Clinical Trials New England, November 6, in Boston. Dr. Colin Hayward will address strategic and practical considerations for engaging with regulatory bodies on the opening day of the annual...

Medical and Regulatory Affairs

5 Reasons to Consider APAC for Clinical Trials

Small and mid-size biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies. In fact, the number of clinical trials in...

Medical and Regulatory Affairs

Curves Ahead: What Brexit Means for Drug Development in the UK

Meet us at PCT Europe 2018! If the United Kingdom’s plan to exit the European Union evokes thoughts of a perilous road of steep grades and switchbacks, you’re pretty well attuned to the politically and commercially fraught process known as Brexit. More than two years after British voters elected to split from the EU, it...

Medical and Regulatory Affairs

Premier Voices #5: Operationalizing the New MDR With Janet Kube (Part 1)

If you sell medical devices in Europe and haven’t made plans to comply with the EU’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), it’s time to step things up. The new MDR and IVDR rules adopted a little over a year ago do have generous phase-in periods — three years for...