Adaptive Design Scientific Working Group
Bayesian Statistics Scientific Working Group
Our members are professionals working in any aspect of the Clinical Data Management (CDM) realm from standards and coding to database design and process improvement. Together we increase the visibility and recognition of CDM as a professional discipline and promote multidisciplinary collaboration and understanding. We use this global forum to share, evaluate, and disseminate information on processes, standards, and technologies for the management of clinical data.
Devoted to helping clinical pharmacologists and other early phase clinicians to collaborate more effectively, this Community provides educational opportunities in multiple formats to enhance understanding of the complexities of Clinical Pharmacology as it applies to the diverse disciplines involved in the entire life-cycle of product development.
Our international forum provides a vital exchange of information about best practices, current clinical trials, and educational opportunities, and fosters communication on a global basis among industry, government agencies, health care delivery systems, and academia on quality in clinical research and health care.
Our mission is to provide a collaborative environment designed to provide a forum to help foster best practices, new ideas, and discuss the changing regulatory environment as it relates to Clinical Safety & Pharmacovigilance (CSP) in order to enhance the practice of monitoring the safety of drugs, biologics, and devices in the interest of public health. Our members are professionals working in any aspect of the CSP realm from and we use this global forum to share, evaluate, and disseminate information on processes, standards, and technologies for the management of safety and pharmacovigilance data.
We cover the entire global clinical trial disclosure and data transparency environment. Members discuss and share operational best practices, new clinical trial disclosure/transparency requirements along with medical, scientific, and regulatory information related to registry and results disclosure activities. Our neutral forum also allows industry, research organizations, academia, and regulators to ‘cross the aisle’ in dialog on these topics.
Our mission is to increase awareness and contribute to the shaping of global legislation for medical devices, in-vitro diagnostics, and combination products.
Focused on document management best practices, emerging technology and concepts, architecture, workflow, records retention, multi-purposing of information, and document repositories, our Community provides the best opportunity for collaboration and contribution to advances in standardization such as the TMF and EDM Reference Models.
Our focus is on regional requirements, electronic submission technologies, electronic document formats and data, expanding types of electronic submissions, and current and emerging standards impacting electronic submissions.
Clinical Trial Disclosure Community: EU Clinical Trial Regulation Working Group
Members of our Community enjoy a professional, neutral forum for discussing issues and sharing medical, scientific, and regulatory information related to Good Clinical Practices (GCP) in Phase I-IV Clinical Trials. We also publicize the field on a global level and engage in the evaluation of GCP quality and compliance issues both in ICH and non-ICH regions. Our working groups keep members updated on such topics as basic GCP concepts, QMS components, and GCP auditing methods and techniques.
We are a group of industry professionals dedicated to exploring practical means for compliance to EU GMP Annex 11 and FDA Part 11 plus GXP predicate rules. Validation of computerized systems involves ensuring fitness for intended purpose and the integrity of electronic information. IQCT members work together to find new ways to effectively deploy technology, people, and processes to achieve trustworthy data and reliable, compliant systems worldwide.
The exchange of scientific and practical knowledge with respect to pharmaceutical law is the primary goal of our Community. We promote this knowledge exchange at an international level through the neutral forum provided by DIA.
Our Community represents all professionals with a focus on innovating communication channels and facilitating scientific exchange with the health care community (health care professionals, patients, consumers, payers, regulators, and academicians). Our mission emphasizes best practices, and provisions for the highest quality medical information for optimal and fully informed clinical decision making. Anyone interested in raising awareness of the medical communications value is welcome to join.
Our Community provides a platform for Medical Science Liaisons (MSLs) across the Pharmaceutical, Medical Device, and Diagnostics industries to network and leverage their experience and expertise to develop best practices that will raise the impact and value of the MSL role and further build upon the integrity of the profession. Regardless of actual title, we welcome anyone working in an MSL related role or with a strong interest in this profession to join and contribute to our MSL Community.
Our Community encompasses the global breadth of medical writing and related scientific communication specialties important to all phases of drug and device development. We provide a neutral forum for discussion of topics and issues related to the medical writing profession, covering regulated and nonregulated documents for the pharmaceutical and biotechnology industries and associated groups. We provide a platform for professional development, global impact, leadership, and networking.
DIA PEC is a learning community for fostering collaboration between those who represent the patient and those who work to integrate patient needs into the process of medicines development, approval and commercialization. We share state-of-the-art advances in patient-industry engagement by enabling 1:1 meetings between advocacy and industry members and by providing forums where we can learn from each other. Every stakeholder is encouraged to participate as a member at large or as a member involved with one of our Working Groups. We strive to grow the community into a leading voice and key advisory resource for patient-centered medicines development.
Members of the Pediatric Community come together to strengthen strategic dialogue between regulators, clinicians, industry, and patients related to pediatric drug development and to encourage and provide training in pediatric drug development.
We support the development of biotechnology, and the professionals involved, by promoting the recognition of biotechnology and the innovative preclinical sciences sector as an important contributor to health care research, and by promoting communication and networking among professionals in the sector. We also address the nonclinical safety issues and challenges associated with the development of oligonucleotide-based therapeutics.