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Great advancements in labeling for pediatric populations have been made but important gaps remain
Honorary Chairs and Keynote Speaker set the tone for action at the life sciences ecosystem’s largest, longest-running meeting June 24-28 in Boston
Advanced digital tools foster a more practical approach to obtaining complete adverse event information versus iterative communication
Many sponsor organizations are wrestling with how to improve the monitoring process with technology in an industry still fresh from the shackles of traditional paper-based data handling.
Better communicating the data and rationale for product approvals builds trust and minimizes suspicion
DIA in cooperation with SureClinical will host a complimentary webinar
Great advancements in labeling for pediatric populations have been made but important gaps remain
Advanced digital tools foster a more practical approach to obtaining complete adverse event information versus iterative communication
Better communicating the data and rationale for product approvals builds trust and minimizes suspicion
The standard of care for patients with early manifestations of certain diseases is careful observation until end-organ damage occurs
Keywords include robotic automation, AI, NLP, patient-centricity and high quality communication
Novel, direct-to-patient registry focused on systematic collection of data on lack of effectiveness
Lack of D&I overlooks benefits and risks of novel medical products in minority populations
US enactment of pioneering PASTEUR Act and UK’s NHS subscription pilot will incentivize development of antibiotics for unmet need
Challenges with ADCs have led to novel ideas such as non-toxic payloads that could convert to an active drug with additional triggers
Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals
Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation: Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2
Guidance: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency
Guidance on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
Best Practices on Conducting Clinical Trials during COVID-19
Johns Hopkins Coronavirus Resource Center: Global Cases
National coronavirus response: A roadmap to reopening
Discussions at DIA 2020 PV & Risk Management Strategies Conference highlight regulatory use of RWD and RWE as more inclusive of true patient experience compared to RTC
AI with NLP can quickly and automatically convert large volumes of unstructured information sources to structured data
Sentinel System projects include evaluating how Natural Language Processing and Machine Learning can address data gaps
Collaborative environment in which to promote industry best practices, generate new ideas, and discuss impact of changing regulatory
According to the 2018 National Youth Tobacco Survey, one in five high school students are users; current use increased 48% among middle school students.
When you hear about investing, you may think about savings and stock accounts. But when it comes to investing in your career, the focus may shift to education, including degrees, didactic courses, certifications, and trainings.
The Canadian opioid crisis is being treated as a public health emergency, and, given its breadth and urgency, a broad range of creative actions are being pursued in the areas of prevention, treatment, harm reduction, and enforcement.
The word diabesity has now been in the mainstream medical lexicon for a decade or so. It refers to the frequent coexistence of...
I recently had the good fortune to attend the European Society of Cardiology’s 2017 Congress, held in Barcelona at the end of…
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The Innovation in Medical Evidence Development and Surveillance (IMEDS) Program, modeled after the Sentinel Initiative...
Pharmacovigilance of patient support programs (PSPs) has been the subject of debate, legislation, and guidance, and regulatory...
Mobile apps and social media are within everyone’s reach, no matter your age or where you’re from. Their potential for good and…
The clinical research industry is changing, and the number of protocols requiring specialty populations for early-phase...
This paper summarizes a discussion that took place at the 52nd Annual DIA Meeting in Philadelphia, PA, on June 30, 2016...
A cross-section of clinical research professionals convened at the June 2016 Drug Information Association annual meeting in...
Rapid advances in technology and our understanding of disease will lead to a shift in how the health care system thinks...
Recent years have seen great interest in finding new ways to develop innovative, safe, and effective medical devices. While...
The purpose of this study was to describe the role of the US Food and Drug Administration (FDA) in ensuring the safety of...
In recent years, pharmacovigilance (PV) has become a high priority, growing public health concern worldwide. India, for...
It is said that there is a “vaccine gap” between Japan and other developed countries. Indeed, the number of available...
In recent years, pharmacovigilance (PV) has become a high priority, growing public health concern worldwide. India, for its...
The UK’s vote in June 2016 to leave the European Union could have profound implications for the pharmaceutical sector in the...
Biopharmaceutical companies are facing increasing pressure to develop more robust pharmacovigilance programs, with teams...
The UK’s vote in June 2016 to leave the European Union could have profound implications for the pharmaceutical sector in the...
Sponsors performing clinical trials in the EU must determine whether serious adverse reactions (SARs) to investigational...
More than 15 years ago, the CIOMS V Working Group observed that, “The recent widespread use of special post-marketing programs...
The DIA Clinical Safety & Pharmacovigilance (CSP) Community aims to help foster best practices, new ideas, and serve as an...
Outsourcing in pharmacovigilance has grown in the past decade. However, standards are lacking in this area, both for...
The isotretinoin risk management program iPLEDGE places requirements on patients and providers to ensure that the benefits...
In the context of the European Union’s Innovative Medicines Initiative (IMI) project titled Web-Recognizing Adverse Drug...
When I was a young boy in pharmacy school, I thought that a pharmaceutical company involved nothing more than the R&D of new...
While benefit-risk (B-R) assessment in the real-world setting is an important challenge for pharmacovigilance, few studies...
In 2012, TransCelerate BioPharma Inc. was launched as a non-profit organization to improve the health of people around the world by…
One of the first DIA 2016 Annual Meeting DIAmond sessions, International Regulatory Convergence, Collaboration, and Cooperation…
Since passage of the Affordable Care Act in 2010, the last several years have seen a groundswell in physician payment and delivery reforms designed to achieve higher value health care through incentivizing higher quality care and lower overall costs.
Honorary Chairs and Keynote Speaker set the tone for action at the life sciences ecosystem’s largest, longest-running meeting June 24-28 in Boston
Many sponsor organizations are wrestling with how to improve the monitoring process with technology in an industry still fresh from the shackles of traditional paper-based data handling.
DIA in cooperation with SureClinical will host a complimentary webinar
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