Clinical Data Requirements for EU Medical Devices: Upcoming Changes


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10 April 2014

Considerations for Clinical Research Outsourcing in Effective Multinational Clinical Studies of Medical Devices

By Karen Jaffe, MS, MBA, RAC

It is no secret that the commercialization of medical devices presents numerous regulatory [Read More...]

9 April 2014

Data Integrity in the FDA-Regulated Laboratory

By Jacqueline McCulloch, RAC, Courtney Woodson and Blake Long

“Data integrity problems break trust. In the time between inspections, we trust you to do the right [Read More...]

19 March 2014

FDA’s Botanical Drug Policy Continues to Develop

By Edward Tabor, MD

As recently as 150 years ago, most pharmaceuticals were obtained directly from plants; now, most are synthetic. However, in the past 20 years, the US Food and Drug Administration (FDA) has seen a future for botanical drug products. [Read More...]

11 March 2014

Project Teams for Regulatory Advisory Committees

By David S. Mantus, PhD

Imagine the end of a voyage. The ship bobs a few feet from the dock. A crowd awaits cargo, and [Read More...]

4 March 2014

Essentials of High-Performing Regulatory Teams

By Naseem Kabir, MS, RAC

The success of a pharmaceutical, biologic or device company hinges on the regulatory team’s ability to deliver on business goals and, for that reason, a high-performing team is a prized asset. [Read More...]

28 February 2014

First Years in a Regulatory Career

By Karen Kurt Teal, PhD

Entering a new field is often a challenge, but knowing what to expect and how others have prepared for it can help. Read what these new careerists have to say about their “novice” period, what their backgrounds are, what their jobs are like and about their advice to others aspiring to enter the regulatory field. [Read More...]

24 February 2014

Clinical Data Requirements for EU Medical Devices: Upcoming Changes

By Mary Couch, MA, RAC (EU)

The European Commission (EC) recently adopted two proposals that, once adopted, will replace the three existing medical devices directives with one regulation for medical devices and another for in vitro diagnostics (IVDs). [Read More...]

18 February 2014

Recruiting for Regulatory - Are We Doing Enough?

By Richard Lem, PharmD

When was the last time someone asked why you chose to work in regulatory? More specifically, what would be your elevator pitch if a recent graduate or a soon-to-graduate student asked you about your career in regulatory? [Read More...]

11 February 2014

The Regulatory Interview: Preparing for Success

By Alyson Sous Andrikanich, PharmD

This view of the regulatory affairs interview process from the other side of the table provides general tips on preparing for an interview as well as specifics for the dynamic and challenging regulatory profession. [Read More...]

16 January 2014

Regulatory Approval of Biosimilars: a Global Perspective

By Gretchen E. Parker, PhD, RAC, Sarah Witwer, JD, RAC, and Gretchen Miller Bowker, MS, RAC, FRAPS

The increasing demand from government agencies, insurers and patients to reduce the steep cost of blockbuster biopharmaceutical products has created considerable opportunities in the global biosimilar market. This article reviews the various regional regulatory processes in effect to date and highlights the need for harmonization.

[Read More...]

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