it is important to begin the drug development process by thinking about drug product labeling requirements in clinical studies and how best to convey this information.
Avoiding Common Pitfalls in the IND and CTA Submission Process [Fill out the form below to register] Abstract: When planning an Investigational New Drug (IND) or Clinical Trial Authorization (CTA) submission, navigating FDA, EMA, and other regulations can be...
A great quality control process assures that the writing is clear, concise, precise, consistent, and scientifically sound while maintaining the document’s structure through the use of standardized templates, style guides, and structured sources and data.
Why You Should Update Your Clinical Trial Disclosure Policy for the EU Clinical Trials Regulation and ICMJE Requirements Now
By Karim Ibazatene, May 12, 2021
This EU Regulation will significantly impact clinical trial registration and disclosure activities, most notably for those Sponsors who have not integrated ICMJE recommendations in their procedures given this may be applied retroactively.
Evolving Your FSP Relationships to Achieve the Maximum Return Learn more about the on-demand webinar by watching this short video. Abstract: The drug development lifecycle can be predictably unpredictable, as mergers and acquisitions, interim results, DSMB...
The concept of regulatory document quality in the pharmaceutical industry derives, in part, from the idea of “scientific data integrity” set out in good clinical practice (GCP) guidance. In practice, the concept of document quality in this regulatory context is structured around key elements that include writing that is clear, precise, concise, consistent, and sound scientifically.
By Samantha Hoopes, PhD, RAC
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on Thursday, October 22, 2020, to discuss the development, authorization, and/or licensure of vaccines to prevent COVID-19. The committee heard from various experts on COVID-19 topics including epidemiology and virology of COVID-19, ongoing COVID-19 vaccines development, considerations for Emergency Use Authorization (EUA) and licensure, plans for post-licensure safety and efficacy monitoring, and vaccine distribution plans.
Modernizing the Functional Service Provider (FSP) Relationship: Innovations to bring value beyond “Global and Scalable”
Given the increasing reliance on global support models, virtual work teams, and the complexity and increasing amounts of data and advancements in technology – sponsor organizations need more from their FSP partners. The best-fit partners bring the functional line expertise plus an innovation mindset and tangible methods to identify, and where requested, help organizations to transform their way of operating.
How Zero Contact GXP Audits Ensure Compliance While Protecting Auditors and Auditees during the Global Pandemic
By Staff Writer, August 27, 2020
Remote, zero contact GXP audits are crucial for auditors and auditees in the pharmaceutical industry to help reduce health risks since the advent of the COVID-19 global pandemic. On-site inspections across pharma and other industries may not be possible due to multiple factors, including restrictions related to travelling, limited access to facilities to minimize health risks, and other restrictions governed by local authorities’ interim policies.
By Christine Clarke, PhD, August 27, 2020
This paper provides a consolidated overview of general information on FDA orphan drug designation requests, and provides sponsors with recommendations and tips for authoring requests, assessing indications, and navigating nuanced areas of designation requests. Specifically, this overview will expound the following areas: the proposed orphan indication, scientific rationale, clinical superiority, subset, prevalence, sponsors’ ideal time for submitting designation requests, and post designation activities. Several example cases are provided to aid understanding.