Regulatory Insights

1. 505(B)(2) Planning: Regulatory And Study Conduct Best Practices 7/15/2020

   Watch this on-demand webinar to hear experts from Worldwide Clinical Trials and Camargo cover the latest trends and early planning recommendations for building and executing a successful 505(b)(2) development program.

2. Understanding New FDA Guidance For Pediatric Oncology Studies 4/21/2020

   The Research to Accelerate Cures and Equity (RACE) for Children Act requires that any original new drug or biologics license application submitted on or after August 18, 2020, for a new active ingredient must contain reports of molecularly targeted pediatric cancer investigations if the drug is directed at a molecular target that the FDA determines to be substantially relevant to the growth or progression of a pediatric cancer. Learn more about the changes in this article.

3. Regulatory Oversight On Gene Therapy In The U.S. And EU 10/9/2019

   Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. With the rapid evolution of the gene therapy field, regulatory agencies have been working to keep pace with these scientific and clinical breakthroughs. An understanding of the regulations and guidance documents reflecting regulator current thinking surrounding gene therapies is essential to success.

4. Cytel's Response: EMA Guidance On The Management Of Clinical Trials During The COVID-19 (Coronavirus) Pandemic 3/25/2020

   On March 20th the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the COVID-19 pandemic. Here is a review of selected elements of the guidance, interpretations and recommendations.

5. CCDS Or Local Labeling, A Chicken-And-Egg Situation? 2/25/2020

   In this blog, UBC’s Dr. Luca Cariolato, Sr. Safety Scientist, speaks to the importance of developing a Company Core Data Sheet (CCDS) before local safety information.

6. Veeva SiteVault: eRegulatory For Clinical Research Sites 1/9/2020

   Watch a 3-minute video to see how clinical research sites can seamlessly manage regulatory documents and process in SiteVault to reduce administrative burden, speed study activation, and improve visibility.

7. The Value Of Data Standards In Clinical Trials: The Time Is Now 12/3/2019

   On an organizational level, failure to establish data standards upfront makes it difficult – and in some cases, impossible to connect data across disparate systems for efficient study execution. The adoption of data standards are necessary to underpin higher data quality, efficiencies and integrated applications across increasingly complex clinical research processes. Continue reading to understand the history of data standards and where they are headed in the future.

8. Drug Development For Rare Disease And Oncology During The COVID-19 Pandemic 10/27/2020

   How has the pandemic affected patients in the search for treatments for rare disease and cancer? How have clinical trials and regulatory activities been impacted? This article outlines some of the findings from a recent virtual discussion with Parexel experts and representatives from the patient advocacy group, Sara’s Cure.

9. Botanical Medicines In Research 4/1/2020

   Botanicals have been used for millennia to combat illness—but why are there so few clinical trials testing the merits of this modality? This white paper describes rationale for why IRBs should embrace botanical medicine protocols.

10. The Challenges Of eCTD Implementation In Small Company And Academic Settings 3/6/2020

    This webinar recording will give an overview of challenges and successes of implementation of eCTD in both a small biotech setting and in academia, as these areas of industry face additional challenges that most midsize and large companies may not have.