Regulatory Insights

  1. Addressing The Data Challenges Of Pharmacovigilance

    As pharmacovigilance adopts next-generation technology by leveraging artificial intelligence (AI) and the cloud, new possibilities are opening up for knowledge generation – and thus value – from the data collected and processed. This paper looks at three important developments around drug safety data and their analysis and how industry is prepared for them.

  2. A New Reality: EMA Published First Guidance On New MDR/IVDR Rules For Certain Devices

    Due to the increasing pace of innovation and blurring boundaries between pharma and device products have led to new drug-device combination products and the need for updated regulatory guidances, the EMA published a Q&A document detailing information for products that need both the drug and the device components to function.

  3. 2018 vs. 2010 FDA Draft Guidance For Industry On Adaptive Designs For Clinical Trials Of Drugs and Biologics

    In September 2018, FDA issued a new draft Guidance for Industry on Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance. Here, we summarize the differences between the two documents and highlight any significant new elements introduced in the most recent material. Of note, the 2018 guidance is more compact and streamlined than its 2010 predecessor, also evident by a fewer number of total pages (36 vs. 50 in the 2010 version).

  4. Innovation, Quality & Expertise – Keys To The Post-Brexit Clinical Landscape

    Many sponsors might have teams dedicated to a post-Brexit clinical landscape – and might have already formulated a plan – but much is still unknown as we enter into new, unchartered territory. For many sponsors, this scenario will be especially relevant for inventory registered within an IRT system manufactured and packaged outside the UK, with the need to be imported in-country. Let’s look at one of most vitals area of concern: drug depots.

  5. Vetting Your Vendor: A Reputation For Success

    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?

  6. Gene Therapies In Rare Disease: From R&D To Regulatory Approval

    Advancements in science and technology have helped researchers develop new treatments for some of the most common diseases known to man. For rare diseases, however, patients have limited treatment options. Advocacy groups and regulatory authorities continue to encourage rare disease research, and more and more scientists are stepping up to the task.

  7. EudraVigilance Survival Guide

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

  8. Ask The IRB Experts

    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.

  9. Cosmeceuticals: How To Navigate The Legal And Regulatory Hurdles Of A Growing Market

    Laws and regulations differ greatly between drugs and cosmetics. Drugs must be submitted for FDA approval. Cosmetics are not. Product manufacturers should know what constitutes a legitimately clinically proven cosmeceutical, as well as what the FDA has to say about these cosmetic-drug hybrids.

  10. MDR: A Landmark Regulation And What It Means For Clinical Research

    We’re at the cusp of a new era for medical device research regulations. What will be necessary to meet new MDR regulations? Data – and more of it than ever. Along with the aims of MDR come a clinical trial data management complexity that might cause some growing pains for the medical device industry.