Regulatory Affairs Editorial

  1. Pediatric Oncology Trials Under FDARA Section 504 — How To Prepare
    12/12/2019

    Although the development of cancer drugs for children is riddled with challenges, the requirements in Section 504 of the FDA Reauthorization Act of 2017 (FDARA) represent a significant paradigm shift in pediatric oncology. Historically, legislative initiatives that support pediatric drug development have had much less impact in oncology than in other clinical areas.

  2. SOP Remediation: When Reinventing The Wheel Is The Best Approach
    11/12/2019

    When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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?

  10. 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.