Industry Taskforce Aims to Standardize Drug Development Training Practice
The International Academy of Clinical Research (IAoCR) has initiated an independent taskforce of industry experts from the international clinical research industry to create a set of best practice recommendations for effective training of all parties involved in pharmaceutical development and manufacturing.
The document, entitled ‘GxP Training Guidelines’, will contain minimum requirements for best practice in training to help introduce consistent training standards across the industry; something that is currently lacking.
The taskforce comprises members from diverse backgrounds including pharmaceutical companies, contract research organizations and independents from Europe, North America and Asia. The consultation process will be extended to a wider group of individuals and organizations from industry, academia, government and regulators on Aug. 1, 2012. The IAoCR is asking that any interested parties register to receive the draft document by using the webform on www.iaocr.com/gxpt. Details on how to provide feedback will be sent along with the draft document.
CEO at IAoCR, Jacqueline Johnson North says: “We understand that in a complex industry such as ours, different parties will make their own interpretations of the training guidelines. It is crucial that we engage the industry in creating the most cohesive, relevant set of recommendations possible. The more people who review this document and provide feedback, the more valuable it will be. We would like the training guidelines to be applicable to all members of the industry across all sectors and would encourage everyone to get involved.”
The draft of the document, along with information on how to provide feedback in confidence, will be available to view or download from Aug. 1, 2012 on the IAoCR website – www.iaocr.com/gxpt-draft. The deadline for feedback is Sept. 21, 2012. After this time, the taskforce will finalize the guidelines ready for publication in October 2012.
It is hoped that the guidelines will be voluntarily adopted across the industry and that this will provide a global framework for best practice. The taskforce will be undertaking a number of conference presentations from October 2012 and throughout 2013.
For more information, please visit www.iaocr.com.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
