Regulatory Affairs Editorial

11. The EU Qualified Person (QP) Demystified 10/29/2019

    For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons may be perceived as a challenge to overcome, because their role and responsibilities are not fully understood.

12. Preparing For Health Authority Inspections: 4 Keys To Inspection Readiness 10/22/2019

    Health authority inspections are one of the most stress-inducing experiences a sponsor, CRO, or site will go through. The mere mention of inspections is enough to throw some people into full on panic-mode. While preparing for an inspection will never be a care- and stress-free process, there are appropriate ways to get your organization ready for one without adding another layer of stress and frustration.

13. 5 Narrative Elements That Will Reveal The Masterpiece In Your TMF 10/15/2019

    In response to the increasing opacity of the trial master file (TMF), clinical trial decision makers have embraced quantitative metrics as a way of characterizing and understanding the health of a TMF. Quantitative metrics are easily generated through the reporting functionality of a modern electronic TMF (eTMF) and appear to add value by leveraging the data passively generated through modern clinical applications. Although helpful to address specific concerns, especially those related to completeness, these metrics are often unintuitive and do not readily describe the aspects of a clinical trial most instrumental for TMF health.

14. Rebiotix Works With Regulators To Define A New Clinical Pathway 10/14/2019

    Rebiotix, a Ferring company, hopes to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. The company is developing their proprietary MRT drug platform, which uses a defined manufacturing process and quality control parameters to assess the impact of human-derived microbiota therapies on patient health and disease.

15. Collaborating With Patients: 3 Key Considerations For Drug Sponsors 10/10/2019

    Historically, patient involvement has been vital in the design and execution of clinical trials, but in recent years there has been an increased desire to engage patients from start to finish during the drug development process. Today, patients are empowered by technological advances that have given them access to more information than ever before, especially regarding diseases and drug development.

16. Tackling Pharmacovigilance Issues In The Clinical Trial Stage Of Product Development 9/24/2019

    Pharmaceutical and device manufacturing companies often outsource their pharmacovigilance (PV) activities to vendors and consultants to meet their safety, medical information, and regulatory needs. When doing so, these companies have a regulatory obligation to oversee the activities and quality of their vendors. However, vendor audits conducted by these companies can yield a wide range of results due to differences in auditors, scope, and understanding of PV principles and operations.

17. How To Conduct Better GCP Audits (Even When You Feel Like An Impostor) 8/22/2019

    How many of us drive to work every day? How many of us know the route so instinctively that we no longer think about where we have to go? It’s easy, right?

18. GenSight Uses Gene Therapies To Target Neurodegenerative Diseases 8/1/2019

    GenSight Biologics believes it is on the cutting edge of ophthalmology, gene therapy, and drug development. The company is focused on finding treatments for patients with neurodegenerative diseases and is developing products that are a combination of gene therapy, its mitochondrial targeting sequence technology, and optogenetics.

19. 3 Surefire Approaches To SOP Harmonization 7/25/2019

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

20. A Tactical Approach To Risk Management At The System-Level 7/10/2019

    Many biotechnology/pharmaceutical organizations are in the early stages of developing their risk management process. For the most part, we tend to see this process developing at the clinical trial level. The struggle with implementing these practices solely at the trial level is that it quickly becomes inconsistent and obsolete. Study teams are taking the time to assess risk as it applies to their trial, but the information gained is seldom shared cross-functionally or upward through an organization. It is more of a “going through the motions” type practice — which is then filed away, never to be utilized again.