REGULATORY INSIGHTS

  • Addressing The Data Challenges Of Pharmacovigilance
    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.

  • 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.

  • 2018 vs. 2010 FDA Draft Guidance For Industry On Adaptive Designs For Clinical Trials Of Drugs and Biologics

    In September 2018, FDA issued a new draft Guidance for Industry on Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance.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).

  • 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.

  • 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?

  • 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.

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REGULATORY MULTIMEDIA

  • Ensuring Safety And Multivigilance Compliance Across The Product Lifecycle

    The regulatory landscape for safety has changed dramatically over the last four years and shows no signs of slowing down any time soon. This Webcast provides an update of the current situation worldwide, a preview of what the next few years will bring, and a solution using Oracle Safety Cloud to remain compliant through it all. Hot topics such as Brexit, combination products, E2B(R3), EVDAS/eRMR, medical device regulations, and IDMP are also included.

  • The Value Of RWD In Safety Signal Refinement

    Population-based RWD are increasingly used by US and EU regulators to complement passive safety surveillance that is based on review of adverse event spontaneous reports. The presentation focuses on a recommended analytic approach for safety scientists, epidemiologists, and other researchers for evaluating the causality of a signal identified from one or more data sources.

  • 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.

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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 and Packaging Services: Pharma
    Unit-Level Serialization and Packaging Services: Pharma

    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.

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