Regulatory Insights
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Are You Ready To Begin Planning Your IND Submission?
5/4/2021
Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a new drug or biologic product. But, are you ready? In this webinar, experts explore the minimum required content for an IND submission and the strategic considerations for developing more than the minimum necessary data before filing an IND.
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Advancing Patient Healthcare: Clarifying The 2019 Changes In India’s Drug And Clinical Trial Rules
3/29/2021
The Ministry of Health and Family Welfare, responsible for all health policy in India, took steps to clarify their regulatory requirements and address many of sponsors’ concerns with the publication of its New Drugs and Clinical Trials Rules in 2019. With these changes, it is worthwhile for sponsors, especially biotech and specialty pharmaceutical companies, to consider the many opportunities that India and other Asia-Pacific countries offer. We have summarized some of the most significant changes in this article.
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Different Approaches For Preparing A Marketing Application
5/4/2021
In this webinar experts explore how to develop your marketing application strategy, analyze the benefits and risks associated with your data migration strategy and coordinate with the medical writing team so that all the information needed to write and complete the modules of the submission is provided with adequate time for review and quality control.
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When RIM Is Not Enough: Overcoming The Limitations Of Document-Driven Systems
6/25/2021
Explore the next stage of regulatory information management. It's time to move past electronic versions of old paper-based processes and see the efficiency that comes with a data-focused approach.
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Market Application And Lifecycle Management: The Road To Commercial Success
5/28/2021
Preparing your market application and planning the lifecycle management of your development program are critical to moving your product through early-phase trials and achieving commercial success. Approval in the United States and European Union paves the way for a drug’s acceptance in many, but not all, other parts of the world — so which additional countries should you consider incorporating in your trial strategy?
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LSX 2021: The Path From Preclinical To And Through Clinical
3/29/2021
Originally presented at the 2021 LSX World Congress virtual conference, this webinar series by Premier experts in oncology, rare disease, and cell and gene therapies focuses on development considerations for advanced therapies, highlighting these products’ unique challenges as well as their powerful potential to address a broad array of unmet patient needs.
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Making The Asia-Pacific Region A Destination Of Choice For Oncology Clinical Trials
8/8/2022
Explore the growth of oncology clinical trials in APAC countries and strategies to support global study success in this dynamic and complex region of the world.
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What Is A TMF Certified Copy?
2/11/2021
When it comes to trial master files (TMFs), questions about original documents and copies are raised more than any other topic. A lot of confusion surrounds two factors: what constitutes a certified copy and when a certified copy is required. While recent regulatory guidance has helped determine best practices that eliminate some of this confusion, questions still remain. This article answers the most frequently and commonly asked questions about the certified copying process for TMFs.
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Advarra - Advancing Clinical Research
6/10/2021
In this video, learn why Advarra is trusted by global clinical leaders to enable safety, compliance, & efficiency in their research. Advarra advances human health, by making clinical research safer, smarter, and faster.
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What You Can Do To Drive Collaboration Across Your TMF
2/10/2021
Previously we had addressed why collaboration should be a key focus for organizations that want to up their TMF quality and inspection game. In this blog learn 5 steps to improve TMF collaboration and inspection readiness.