Concept Papers establish or clarify a concept (or framework); they often describe a potential solution or approach to an existing problem or area of discussion. These papers may interpret or clarify a regulatory position, and may seek to influence.
|Remote Observation Technologies in the Pharmaceutical Manufacturing Space||June 2018|
|Data Privacy: A Compliance Blind Spot||June 2017|
|Role of Process Capability in Monitoring Product Quality||May 2017|
|Leveraging PaaS in a Regulated Environment||July 2016|
|Saas in a Regulated Environment||July 2016|
|Using Saas in a Regulated Environment||July 2016|
|Considerations for Corporate Data Integrity Program||March 2016|
|Improving Access for Patients with Unmet Medical Needs||June 2014|
|Validation & Data Integrity in eClinical Platforms||June 2014|
|GAMP 5: Implementation & Operation of GxP Compliant Clinical System||September 2013|
|Controlled Temperature Chamber Mapping||April 2012|
|Implementing Knowledge Management in Bioprocesses||March 2012|
|Use of Booklet Labels on Investigational Medicinal Products (IMPs)||February 2012|
Discussion Papers promote discussion and creates awareness on new or emerging topics; they often solicit feedback, gauge interest, and seek member or industry input. They may state a problem, provide the tentative exploration of solutions and options, and may suggest potential next steps.