Regulatory Insights

1. Safety, Pharmacovigilance, And Risk Management Plans In China 1/27/2020

   China joining the International Council for Harmonization (ICH) in 2017, and China’s subsequent announcement to follow relevant ICH guidelines such as E2, M1 and M4 in 2018, is continuing to change the conduct of pharmacovigilance in China. Read more about the aspects of these regulatory changes and resulting industry needs.

2. Panel Discussion On IDMP And Data Preparation 1/29/2021

   In this webinar, our panel of experts will discuss the innovative approaches they are taking to manage IDMP, a vital part of pharmaceutical commercialization. Topics will include ways to improve data processes across the regulatory lifecycle by utilizing advanced technologies such as AI-driven automation.

3. The Regulatory Evolution And Data Revolution In Medical Device Development 7/4/2020

   The Life Sciences and Healthcare industries are among the most heavily regulated industries in the world. This paper looks at the current, dynamic regulatory landscape within the medical devices sector and some of the current and future changes medical device organizations will need to adhere to. The in-vitro diagnostics (IVD) sector is also going through regulatory change - a topic that is out of scope for this paper.

4. Snapshot: A New Guidance Document Program From The FDA 4/21/2020

   In a progressive effort to mitigate these long-standing concerns and bring a level of clarity to its guidance documents, the FDA has created a pilot program called “Guidance Snapshots.” As experts, we are always debating about what the guidance is asking and how the contents are to be applied.

5. Regulatory Compliance: An Increasing Burden On Sites 6/25/2020

   As the biopharmaceutical industry strives to reduce its R&D costs and shorten timelines, it must face the fact that today’s successful drug development plans often require more clinical studies than they did a dozen years ago. But a new CenterWatch survey, sponsored by Complion, sheds some light for the first time on how, and how well, sites manage regulatory compliance.

6. Centralized IBC Review Benefits On Research 4/1/2020

   Gene therapy research is beginning to boom in the clinical setting. This blog summarizes the growth, risks, and regulatory requirements for gene therapy research.

7. Unsustainable And Burdensome: Today’s Safety Reporting Fails Sites, Sponsors And Patients 5/21/2021

   Safety reporting is one of the last areas of hidden cost and inefficiency in clinical trials today, costing sponsors millions or tens of millions of dollars each year in excessive site payments and monitoring costs on unnecessary or duplicate safety reporting. Few receive value for their investment, and some don’t even know how much that investment is.

8. Global SUSAR Distribution: Lack Of Regulatory Harmony Puts Trials At Risk 5/21/2021

   The lack of global regulatory harmonization undermines safety reporting efforts, putting patients at risk and adding millions of dollars to the cost of a trial. We’ve seen at least 40 different approaches in terms of how countries handle SUSAR distribution—and it all changes regularly. It is difficult to conduct this global process correctly and the consequences of making mistakes are severe, including potential risks to patient health, regulatory repercussions, delays, or even having a trial shut down.

9. The Summary Of Safety And Clinical Performance (SSCP) For Healthcare Professionals And Patients 4/22/2021

   While the new regulations on medical devices and in vitro diagnostics aim to reduce risks associated with medical devices, their implementation calls for a focused effort from device manufacturers. One particular document presents a challenge for manufacturers, since they will need to consider patients a target audience. Article 32 of the MDR requires creating a summary of safety and clinical performance (SSCP), which device manufacturers will need to prepare annually to remain in compliance with the regulation.

10. Vendor Oversight – Ensuring Regulatory Compliance By Assessing Study Risks 3/22/2021

    ICH E6 (R2) introduces the concepts of vendor oversight and risk management, but have these requirements been implemented jointly or as separate initiative’s today? Is study risk also being taken into account in vendor oversight? In this webcast we will explore the intended purpose of ICH regulations to implement industry best-practices, how current vendor oversight practices need to evolve to ensure compliance with recent regulatory guidance’s and how by implementing QbD in your operational processes you can ensure study risk assessment in your vendor oversight – end-to-end.