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.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
