Regulatory Insights

  1. Insights Into Medical Device Regulations From MAGI 2017 West
    12/19/2017

    Regulatory experts outline some of the regulatory changes on the horizon for the medical device industry.

  2. Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs
    12/26/2018

    Explore the many aspects a company must consider in planning and executing an early-phase oncology trial of this hypothetical compound, from performing a regulatory gap analysis and developing a target product profile to identifying the right patients and selecting efficacy endpoints.

  3. EudraVigilance Survival Guide
    5/14/2019

    What it is, why it is important, and what sponsors need to think about as it gets closer.

  4. Recent FDA Updates And Guidance For Rare Disease Drug Development Webinar
    5/7/2019

    In January 2019, the US Food and Drug Administration (FDA) updated its 2015 draft guidelines for drug discovery in rare diseases. The update, Rare Diseases: Common Issues in Drug Development, seeks to help pharmaceutical companies and other sponsors perform more efficient development programs for drugs and biological products and provides new insights on complex elements of the development process. In this webinar, learn about the core elements of the new guidance plus the latest recommendations and instructions from the agency along with practical examples and applications.

  5. Ask The IRB Experts
    5/9/2019

    Clinical research is complicated.  At WCG, we frequently get questions about the ethical conduct of research from clinical team members at biopharma companies and study sites. We know that for many of the questions we get, the person asking is not the only one struggling with that issue. Read the questions your peers are asking – and if you don’t see yours, submit one of your own.

  6. Understanding Recent Regulatory Changes For Pediatric Oncology Trials
    11/14/2019

    While children typically have a better cure rate for cancer, biopharma companies have traditionally shied away from pediatric oncology trials, resulting in fewer treatment options. However, the regulatory landscape is evolving, and the demand for innovative therapies for pediatric cancers is becoming increasingly vocal.

  7. From Laboratory To Bedside: Expediting Development Of Novel Rare Cancer Treatments
    12/27/2018

    This webinar shares new insights on rare oncology drug development and examines how new processes and regulatory pathways are helping speed development of novel therapies.

  8. Vetting Your Vendor: A Reputation For Success
    5/28/2019

    When researching vendors, particularly in the tech space (and especially in clinical trial disclosure), you should look at more than just the price tag. Do your due diligence. How long has the vendor been in business? What does its client roster look like? What kind of reputation does it have in the industry?

  9. Clinical Trial Transparency: The Technology Imperative
    10/4/2018

    This paper looks at clinical trial transparency and the driving forces behind it to better understand the role of technology in the execution of a solid clinical trial transparency policy.

  10. Changes to WHODrug Are Coming – Will You Be Ready?
    8/18/2018

    Why you should prepare now even with nearly a year remaining.