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"My involvement in DIA Communities keeps me current on developments in my area and provides opportunities to discuss ideas with a group of professionals who bring different perspecrtives to the table, enriching my professional network.“
Robert Paarlberg, Principal, Paarlberg & Associates LLC; DIA Clinical Trial Disclosure Community Chair
"Through my involvement with DIA Communities, I’ve met many talented colleagues from around the globe, from disciplines that are different from my own. That provides me with the opportunity to share how my area of expertise can be of value across different functions, and learn about others that have a positive effect on my own work.“
Joan Buenconsejo, PhD, Director & Biometrics Team Leader, Biometrics & Information Sciences, Astra Zeneca; DIA Regulatory Affairs Community Chair
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.
Clinical Safety & Pharmacovigilance
We provide a collaborative environment designed to foster best practices and new ideas for enhancing the safety of medical products in the interest of public health. The professional needs of our members are supported through high quality training, peer interaction, and opportunities for personal growth.
Clinical Trial Disclosure
We cover the entire global clinical trial disclosure and data transparency environment. Members discuss and share operational best practices along with medical, scientific, and regulatory information related to registry and results disclosure activities. Our neutral forum also allows industry, academia, and regulators to “cross the aisle” in dialog on these topics.
Document & Records Management
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.
Electronic Regulatory Submissions
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.
Ethics & the Medicines Lifecycle
Established to help regulators, academics, industry, government, and community stakeholders reflect more explicitly on ethical concerns within their practices. We tackle the difficult moral questions that can only be resolved through reflection and discussion about what we want from our health systems, industry, and research institutions.
Good Clinical Practices & QA
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.
Our Community represents all professionals with a focus on enhancing communication channels and dialogue among healthcare professionals, patients, consumers, payers, regulators, and academicians. Anyone interested in raising awareness in the value of medical communications is welcome. Our mission emphasizes best practices and provisions for the highest quality medical information.
Medical Science Liaison
This is a place for MSLs to leverage their experience and expertise to develop best practices that will raise the impact and value of the MSL role and further build the integrity of the profession. Regardless of actual title, anyone working in the function of an MSL or with knowledge and insight to share is invited to join.
Composed of medical writers from every niche of the pharmaceutical and biotechnology writing fields, across every phase of the drug development process worldwide – including regulated and unregulated documents – we advance our discipline while encouraging dialogue between regulators, academia, and industry.
We unite those who represent the patient with anyone interested in increasing patient engagement and robust patient involvement ranging from protocol design and review to data safety monitoring boards and IRBs. Every stakeholder in the research continuum is encouraged to participate as a member at large or as a member involved with one of our Working Groups.
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.
Preclinical Sciences & OSWG
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.
Professional Education, Training & Development
With a mission focused in three distinct areas – education, training, and professional development – we are a global professional community dedicated to enhancing the abilities of those involved in medicines research and development, as well as promoting career satisfaction.
The Project Management Community supports the development of project management professionals in the global pharmaceutical industry. Our members promote the recognition of project management professionals as the pharmaceutical industry's development specialists, and also promote the education and training of project managers to ensure professional success and growth.
Regulatory Affairs professionals – across the global product development industry – join this Community to share best practices and to discuss non-proprietary topics and techniques for regulatory activities related to development and commercialization in the biopharmaceutical environment of products intended to diagnose, treat, and cure illnesses.
We support the development of a community of practice for statisticians in the biopharmaceutical and healthcare industries, including academic and government sectors. Our mission includes providing global forums for the sharing of statistical knowledge and experience, and identifying and responding to the educational and professional development needs of the Community.
Health care professionals involved in the selecting, developing, analyzing, or interpreting of study endpoints are invited to join our Community. We are focused on advancing the scientific development and evaluation of study endpoints and educating other health care professionals about those developments.
Val/Electronic Info Integrity
Together we address electronic information integrity and computerized systems integrity for GxP regulated environments. This is a highly collaborative Community where members work together to find new ways to effectively deploy technology, people, and processes to achieve trustworthy data and reliable, compliant systems.