REGULATORY INSIGHTS

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

  • EudraVigilance Survival Guide

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

  • 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.

  • 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.

  • 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.

  • Small But Growing Biotech Manages Disclosure, Maintains Compliance, And Keeps Its Promise To Patients

    For this biotech, the big challenge was both a lack of expertise and resources needed to manage registration of trials and posting results.TrialScope provided a proven solution that optimizes the eciency of disclosure activities,
    maximizes trial data transparency, and fosters more informed, engaged patients through open research sharing.

More Regulatory Insights

REGULATORY MULTIMEDIA

  • Recent FDA Updates And Guidance For Rare Disease Drug Development Webinar
    Recent FDA Updates And Guidance For Rare Disease Drug Development Webinar

    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.

  • Risk Evaluation And Mitigation Strategy (REMS) Overview

    UBC’s Natalie O’Donnell, Executive Director, SERRM, provides a Risk Evaluation and Mitigation Strategy (REMS) overview. Learn more about the importance in partnering with an experienced REMS team for your next study.

  • Taking The Fear Out Of Software Implementation

    Software implementation does not have to be a scary proposition. In this video, implementation experts – with a 100% success rate – discusses what works and why.

  • Right-To-Try Or Right-to-Ask? Understanding Right-To-Try And FDA’s Expanded Access

    Right-to-Try has been in the news a lot recently, but what does it actually mean for product sponsors? This webinar explores both Right-to-Try legislation and existing Expanded Access Programs, including understanding sponsor responsibilities under these programs and when products may be eligible for these programs, evaluating options such as treatment protocols, treatment INDs, and emergency use, and discussing development risks associated with participation in these programs.

  • Development Advice For Gene Therapy Products

    This webinar will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and CMC development

  • Understanding FDA’s Priority Review Voucher System

    How can one regulatory program simultaneously benefit both blockbuster drugs and rare or neglected diseases? How can your company leverage the opportunities afforded by this program? In this complimentary webinar, Rho’s panel of experts will walk you through the how’s and why’s of the FDA’s Priority Review Voucher program.

More Regulatory Multimedia

REGULATORY SOLUTIONS

  • Clinical Trial Management Brochure

    For more than 25 years, Bellwyck has been a true partner in developing smarter solutions for the pharmaceutical industry — from clinical trial to commercialization. Our consulting services start with a dedicated project management team led by a single point of contact throughout your project.

  • Unit-Level Serialization
    Unit-Level Serialization

    While regulatory compliance is a major driver for serialization projects, breaches to the Pharmaceutical Supply Chain distribution system are also a concern, as they can pose health risks to patients and financial risks to the supply chain stakeholders. At Bellwyck, our holistic and comprehensive approach to serialization ensures these risks will be mitigated and will maximize your value. We have partnered with industry leader Optel Vision to provide you with a flexible serialization solution that can meet a wide range of requirements.

  • How Biorasi Optimizes Clinical Solutions

    Best-in-class processes coupled with industry-leading technology to fight for your trial’s success.

More Regulatory Solutions