This page features some knowledgeable people writing on current topics of interest. I am pretty proud of the impressive list of Guest Contributors that have graced the pages of GxP Perspectives. One of the philosophies of this blog is that a lot of the common problems facing public health and drug & device development could be solved by those of us who do the work. That’s why I want to hear from GxP professionals on areas of their expertise. If you have a topic you wish to write about, please let me know!
Our newest Guest Commentary comes from Judith Lynn in her second contribution to GxP Perspectives. This one is on:
FDA Draft Guidance on Risk-Based Monitoring, Part II
Lorraine Ellis. kicked off discussion on the August 2011 FDA Draft Guidance on Risk-Based Monitoring (Part I).
Veteran GxP Consultants Len Grunbaum and Emma Barsky wdiscuss auditing best practices:
Audit Techniques and Etiquette.
Then we have former FDAer and President of Moriah Consulting, Michael Hamrell, PhD on
Proposed User Fees for Biosimilars
Kathie Clark discusses EU & FDA cGMP Documentation Requirements for Approvals and Signatures
The SOP Doctor, Dr. Marie McKenzie Mills MICR, CSci, CBiol, MSB, a clinical scientist and trainer from the United Kingdom. on
SOP Requirements for GCPs in Europe.
Mark Stecker, the Wheelchair Kamikaze, writes on a
Patient Perspective on Medical Research
Steven Steinbreuck discusses Informed consent: New Rule on Informed Consent
Here is a topic that I know almost nothing about, by Jill Petro of Aureus Research. She discusses contracts for clinical sites. That is why it is exciting to have Guest Commentaries. I get the chance to learn!
The good professor, Sid Olufs, has a recent Guest Commentary out on REACH: The European Regulation of Chemicals
TMF Reference Model: Everyone wants to know about the work Karen Reddy, co-chair of the TMF Reference workgroup for DIA, is doing. She writes about: The TMF Reference Model Explained.
Veteran GxP Consultant Len Grunbaum of Practical Solutions NJ discusses:
Our most popular commentary is by Barb Immel on corrective and preventive actions: CAPA Basics
The highest ratings belong to Mikki O’Neal who writes about GCP Training on Informed Consents
Here is a two-part commentary on the importance of training and education in our profession and also highly rated. In fact, the guest commentaries get higher ratings than Carl:( This Commentary was reprinted in GxP Lifeline Master Control Newsletter!
Part One of Nancie Celini’s treatise on GxP Education-
Part Two, which, logically follows part one
A special commentary from Germany by Professor Gerhard Fortwengel on a study showing Bias in Clinical Trials Sponsored by the Pharmaceutical Industry
Judith Lynn talks about managing studies and: Keeping Protocol Deviations in Check
Louise Johnson explains the ins and outs for Ten Tips for Regulatory Submissions
Sid Olufs, our very own book reviewer, has the first Guest Commentary that the Blog posted in January on changes in FDA’s regulation of food:
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Carl is solely responsible for the content of the Blog. Guest contributions are the viewpoints of the guest contributors. Please inform Carl if there are any errors that need correcting. Although this blog is commentary, I hope that the commentary is based on an accurate understanding of events. Please let me know your views.