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21
Feb
U.S. Sites Play Surprise Starring Role In FDA’s Drug GMP Warning Letter Report

Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

Posted in: FDA, Manufacturing,
Tags: GMP, GMP compliant, inspections, warning letters,
18
Feb
Extension Of The Patient: Expanding The Role Of Caregivers In Biopharma Development

For medical product developers, the role of the caregiver is increasing as innovation advances. Caregivers may provide input on clinical trial concepts, protocol design, informed consent creation, and may also improve clinical trial recruitment and retention.

Posted in: Clinical,
Tags: biopharma development, caregivers, patient, PFDD,
13
Feb
First Impressions Matter: The Importance Of CRO Introductory Meetings

Pivotal first meetings with sponsor representatives or investigational sites set the precedent for future relationship development. They often serve as the introductory vehicle for key study players and require finesse to ensure success. For these reasons, all early interactions are something sponsor companies should pay close attention to.

Posted in: Clinical,
13
Feb
Cats In The Warehouse! 9 More Real-Life Blunders To Avoid In Your Pharma Facility

Our previous review of humorous and horrifying pharmaceutical facilities blunders Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them) revealed our industry is flawed like any other. Here are some examples from the engineering side of the business.

Posted in: Manufacturing,
Tags: aseptic plant, CGMP, facilities, facility, GMP,
12
Feb
Implementing QbD In Your Clinical Trial? 4 Questions To Answer First

Quality, as it relates to clinical trials, is defined as an absence of errors that matter to decision-making. Therefore, quality by design (QbD) literally translates into an absence of errors that matter to decision-making by design. This proactive approach to quality continues to gain global and regulatory support. In fact, on May 8, 2019, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft revision of ICH E8 (R1), General Considerations for Clinical Studies.

Posted in: Clinical,
Tags: clinical trial design, ICH E8, QbD, quality by design,
11
Feb
3 Health Tech Trends Shaping The Future Of Clinical Operations

It can be overwhelming to keep up with the rapid pace of health technology advancement; in many ways, it feels like we’re just along for the ride. Let’s fast forward and take a look into three key areas of innovation that are forcing us to face and embrace a changing technological landscape in clinical research.

Posted in: Clinical,
Tags: artificial intelligence, clinical research, interoperability, machine learning,