Medical and Regulatory Affairs

Are You Ready for the FDA’s eCTD Filing Deadline? That’s May 5, 2018. Yes. Tomorrow.

It’s already been three years since the FDA issued its “Guidance on Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” This guidance established a mandatory requirement for electronic submission of certain applications, amendments, supplements, and reports to the FDA’s Center for Biologics Evaluation and Research (CBER)...

Where Expertise Meets Nuance: Conducting PTSD Clinical Trials

The invisible wounds caused by post-traumatic stress disorder can dramatically affect mental health and diminish quality of life. According to the Sidran Institute, a nonprofit organization serving people who have experienced or witnessed traumatic events, PTSD is associated with an extremely high rate of medical and mental health service use. Patients may incur the highest per-capita cost...

The Regulatory Landscape for Immuno-gene Therapeutics in Hematological Malignances

Over the past few years, there has been a dramatic increase in the use of genetically modified cells for cancer immunotherapy, including chimeric antigen receptor (CAR)-T cells, recombinant T-cell receptor T cells and genetically modified CD34+ cells for the treatment of hematological malignancies. Clinical trials of immuno-gene therapeutics are becoming increasingly common, and regulatory guidelines...

Learning to Listen: Voice of the Patient Grows Louder in Product Development

Days before Christmas 2017, a nationwide call went out requesting nominations of patients and caregivers to join a new public/private-sponsored Patient Engagement Collaborative. Among the promised duties for this yet-to-be-filled body of 16 patient community representatives: Propose new collaboration models in which patients and patient advocates are partners in healthcare product development and U.S. Food...

7 Questions About Clinical Evaluations for MDR

After years in development, the final version of the Medical Device/In Vitro Diagnostic Medical Device Regulations was published in the Official Journal of the European Union on May 5, 2017. These regulations superseded the previous Directives for the European market and will be implemented over the next few years. In our last post, we went over...

Europe’s Medical Device Regulation: Get to Know the Basics

The regulatory landscape for medical devices in Europe is undergoing some major changes. Published in May 2017, the new European Medical Device Regulation (MDR) (Regulation [EU] 2017/745) and In Vitro Diagnostics Regulation (IVDR) (Regulation [EU] 2017/746) is gradually replacing the Medical Devices Directive and the Implantable Medical Devices Directive in the European market. Although the...

ICH GCP Update: Sponsor Control of Clinical Trial Data

Under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), sponsors have extensive responsibilities for ensuring not only the ethical and scientific quality of clinical trials, but also the protection of study participants and the integrity of clinical trial data. The recent update of...

Experts to Discuss EU Regulations at OCT Medical Devices Europe

DURHAM, N.C., February 6, 2018 — Two Premier Research medical device experts will examine the impact of upcoming changes to European medical device regulations at Outsourcing in Clinical Trials Medical Devices Europe 2018. Joanne Emmett, Vice President for Medical Device and Diagnostics, and Janet Kube, Director, Project Management, will discuss the new EU Medical Device...

Drug Development & Delivery – Device Regulations, Early Preparation Will Pay Big Dividends as EU Enacts New EU Device Regulations

Drug Development & Delivery – Device Regulations, Early Preparation Will Pay Big Dividends as EU Enacts New EU Device Regulationsby Joanne Emmett, Vice President, Medical Devices

Updates to the ICH GCP (Good Clinical Practice) Guidelines: Quick Review

First produced in June 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that involve human subjects. The objective of the standard is to ensure that...

Medical and Regulatory Affairs