Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

833
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
833
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

158
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
158
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

126
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
126
Drug Discovery: Overview01:26

Drug Discovery: Overview

7.9K
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
7.9K
Structure-Activity Relationships and Drug Design01:28

Structure-Activity Relationships and Drug Design

718
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
718
Drug Regulation01:25

Drug Regulation

1.4K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.4K
  1. Home
  3. Research Domains
  5. Commerce, Management, Tourism And Services
  7. Accounting, Auditing And Accountability
  9. Auditing And Accountability
  11. Industry Perceptions And Experiences With The Access Consortium New Active Substance Work-sharing Initiative (naswsi): Survey Results And Recommendations

Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations

Gaia Geraci1, Robert Smith2, Alison Hansford3

  • 1Clarivate, 70 St. Mary Avenue, London, EC3A 8BE, UK. gaia.geraci@clarivate.com.

Therapeutic Innovation & Regulatory Science
|March 8, 2024

Related Experiment Videos

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

9.6K
Drug-induced Sensitization of Adenylyl Cyclase: Assay Streamlining and Miniaturization for Small Molecule and siRNA Screening Applications
09:39

Drug-induced Sensitization of Adenylyl Cyclase: Assay Streamlining and Miniaturization for Small Molecule and siRNA Screening Applications

Published on: January 27, 2014

12.7K
Author Spotlight: Scalable Drug Screening Protocol for Efficient Discovery of M. abscessus Treatments
07:50

Author Spotlight: Scalable Drug Screening Protocol for Efficient Discovery of M. abscessus Treatments

Published on: October 25, 2024

1.6K

View abstract on PubMed

Summary
This summary is machine-generated.

The Access Consortium initiative for new active substance review generally receives positive feedback from pharmaceutical companies. Improvements in predictability, guidance, and process streamlining are recommended to enhance participation and patient access to medicines.

Area of Science:

  • Regulatory Science
  • Pharmaceutical Policy
  • Drug Registration

Background:

  • The Access Consortium facilitates joint regulatory reviews for new active substances and indications.
  • Industry participation in the Access initiative is voluntary, making stakeholder perceptions crucial for its success.

Purpose of the Study:

  • To gather insights into the perceptions and experiences of pharmaceutical company affiliates regarding the Access pathway.
  • To identify factors influencing participation and areas for improvement within the Access initiative.

Main Methods:

  • A survey was developed by pharmaceutical industry trade associations in Access Consortium countries (Australia, Canada, Singapore, Switzerland, UK).
  • The survey was distributed to pharmaceutical company affiliates to collect data on their experiences with the Access pathway.
Keywords:
Access consortiumCollaborationNASWSIRegistration

Related Experiment Videos

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

9.6K
Drug-induced Sensitization of Adenylyl Cyclase: Assay Streamlining and Miniaturization for Small Molecule and siRNA Screening Applications
09:39

Drug-induced Sensitization of Adenylyl Cyclase: Assay Streamlining and Miniaturization for Small Molecule and siRNA Screening Applications

Published on: January 27, 2014

12.7K
Author Spotlight: Scalable Drug Screening Protocol for Efficient Discovery of M. abscessus Treatments
07:50

Author Spotlight: Scalable Drug Screening Protocol for Efficient Discovery of M. abscessus Treatments

Published on: October 25, 2024

1.6K

Main Results:

  • Affiliates participating in the Access pathway reported mostly positive experiences and satisfaction with regulatory authority interactions.
  • Key reasons for non-participation included lack of opportunity and perceived complexity of the Access pathway.
  • Willingness to continue participation was observed among those who had engaged with the initiative.

Conclusions:

  • The Access Consortium initiative is perceived positively by participating industry affiliates.
  • Recommendations for improvement focus on enhancing predictability, transparency, process efficiency, flexibility, harmonization, and regulatory authority-industry collaboration.
  • Addressing perceived barriers and increasing opportunities can foster greater industry engagement, ultimately accelerating patient access to innovative medicines.
Regulatory
Work-sharing