February 6th 2024
GenAI is on the precipice of making regulatory strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.
November 2nd 2023
New laws leave consumers unprotected against third parties accessing their genetic data.
October 13th 2023
Agency will be reorganizing field force and compliance functions.
September 27th 2023
Exploring the implications of FDA’s renewed focus and commitment to expand the use of accelerated approval for gene therapy products.
EU proposal focuses on a subset of underserved rare diseases—exploring the gaps in those conditions for which there is no approved treatment option.
Navigating the Complexities of Clinical Trial Budget Forecasting and Payments
Webinar Date/Time: Option 1: Thursday, February 1st, 2024 at 9am EST | 6am PST | 2pm GMT | 3pm CET Option 2: Thursday, February 1st, 2024 at 2pm EST | 11am PST | 7pm GMT | 8pm CET
Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices
Webinar Date/Time: Wed, Jan 17, 2024 12:00 PM EST
Veeva R&D and Quality Summit 2023: Q&A With Scott Cleve, Vice President of Regulatory Operations, Information, & Compliance at Daiichi Sankyo
Cleve talks about the future of the industry and how data remains a key focus.
The EU Regulations Catching US Pharma Companies Off Guard
Companies that understand the regulatory environment in Europe can keep their trials on budget and on schedule.
Navigating Inflation and Workforce Shifts: Advancing Clinical Site Budgeting Strategies
Webinar Date/Time: Thursday, October 26th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
More than Just Rules: Raising the Bar in GCP Adherence
Stepped-up training and real-time application key to avoiding compliance pitfalls.
Proposed ICH-GCP E6(R3) Guidance: Principles in Action
How to support trial investigators through decentralization of trial elements.
Importance of DCTs Moving Forward
Perceived barriers of DCTs can be quickly overcome to ensure their viability in clinical research.
How to Operationalize Your DCT or Hybrid Trial: Best Practices for Emerging Biopharma
Webinar Date/Time: Tue, Sep 19, 2023 11:00 AM EDT
Speeding Up European Clinical Trials in Response to Emergencies
With lessons from COVID now established, concrete ideas on improving drug development strategy for future health threats are beginning to take shape.
ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?
Collaboration and regulation were the watchwords at DIA Global this year, where the ICH E6(R3) guideline, published in final draft form in May, was the talk of the congress.
FDA CID Paired Meeting Requests for Q3 Open
Designed to facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs, the program provides an opportunity for sponsors to interact with experts from FDA.
To Validate SaaS or Not to Validate SaaS? That is the Question…
Webinar Date/Time: Wednesday, September 13th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
How Modeling Can Help to Improve Children’s Access to Properly Evaluated Medications
Regulatory guidance paves the way to address ethical concerns in pediatric trials, and how additional strategies can be applied in drug evaluation.
Navigating the FDA's Draft Guidance on DCTs—A Roadmap for Trial Sponsors
Webinar Date/Time: Wednesday, August 16, 2023 at 11am EDT
Spontaneous Reporting System for Adverse Drug Reactions in Germany
While underreported, ADR data offers significant value to the drug development value chain to refine the predictive capability and stability, and provide enhanced patient safety.
Cultivating a Culture of Quality
Insights from Clinical Quality Oversight Forum.
DIA 2023: Medical Device Regulators and Harmonization
Session at DIA discusses the International Medical Device Regulators Forum (IMDRF), its importance and how harmonization could be improved.
DIA 2023: FDA Rare Disease Town Hall
CDER and CBER leaders update initiatives in the rare disease space within the past year.
How to Incorporate the Patient Voice for Inclusive Medical Communications
Webinar Date/Time: Thu, Jul 20, 2023 11:00am EDT | 4pm BST | 5pm CEST
FDA Issues Draft Guidance on Psychedelics
First guidance in this area from the Agency addresses the unique challenges when designing clinical studies for these drugs
FDA Launches Pilot Program Using Cancer Biomarkers to Mitigate Risk
FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.
The African Medicines Agency: Impacts on the Continent’s Clinical Trials Regulation
Harmonization could turn the continent into an established site for clinical research and laboratories.
FDA On Track to Update Diabetes Efficacy Endpoints Guidance
This latest guidance provides a 15-year update on the recommendations, including the use of CGM devices.
European Legislative Proposals Presage New Rules for Clinical Trials
EU’s sweeping push for major pharma reforms to impact the daily practice of clinical trials community.
Transformations Past and Future for the European Medicines Agency
Dissecting the EMA’s new annual report on milestones reached in clinical research and public health.
Optimal COA Measurement Strategy in Modern Oncology Trials
Examining the two areas of weakness cited in FDA draft guidance.
Evolving Tools and Perspectives for the Development of Cell and Gene Therapies
Stakeholders must alter their mindsets when it comes to early-phase design and interpreting regulatory guidance for CGT trials.
Unlocking the Potential of eClinical Technologies
Key considerations for successful implementation in decentralized clinical trials.
EU Perspectives: Guidance for Using Patient Experience Data in Real-World Studies
Patient insights are expected to become increasingly instrumental in optimizing medicine development and regulatory decision-making.