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.
By Patrick Hannon, et al, July 10, 2020
In order to better understand the data being reported from the COVID-19 public health emergency that has gripped the world in recent months, it is helpful to understand the mathematical and statistical considerations of binary classification tests. These include COVID-19 antigen tests (patient has the active pathogen in their body) and COVID-19 anti-body tests (patient has been exposed and has mounted an immune response).
Download the whitepaper on “Pharmaceutical Industry Challenges Facing Clinical Trial Disclosure and Transparency.” While global regulatory authorities routinely update clinical trial disclosure and transparency requirements, new regulations set to take effect in 2020 and 2021 will dramatically change how sponsors report clinical trial data.
Each month, MMS shares key stories on the evolution of the pharmaceutical industry. Here is a selection from May, including: FDA Coronavirus (COVID-19) Update, 2019 Avoca State of the Industry Report, PHUSE clinical trial transparency project, and more.
Join us for an Expert Insights Webinar on May 27 titled “Recommended Changes for Pharma Companies in Response to COVID-19”
By Staff Writer, April 30, 2020
Each month, MMS shares key stories on the evolution of the pharmaceutical industry. Here is a selection from April 2020.