In December 2015, FDA released a draft guidance on safety assessment for IND safety reporting in support of the changes in the IND safety reporting regulations.
In the face of dwindling drug pipelines, stringent drug regulations, and block-busters crossing their patent exclusivity, mature and established products offer an opportunity for companies to sustain their revenues and bottom lines in the increasingly challenging pharmaceutical market.
Poor quality ICSR data impacts the ability to conduct safety surveillance activities and forces regulators and independent groups to question the overall quality of the pharmacovigilance system.
This webinar offers a unique perspective on the current state-of-the-art applications of RWE by stakeholders like regulators and payers. It also explores the future potential of technologies like AI, Blockchain and IoT to leverage and optimize RWE use for exponentially accelerating patient access.
Real World Data (RWD) is defined as data collected outside the controlled constraints of conventional randomized clinical trials to evaluate what is occurring in routine clinical practice.
The webinar discusses the new and improved EudraVigilance database which was accompanied by updates to GVP Module VI (ICSR and Safety Reporting) and Module IX (Safety Signal Management).
This webinar will evaluate warning letters from the perspective of small and large pharmaceutical companies. The expert PV panel will present best practices and recommendations that can be employed to improve a PV organization's structure, develop appropriate SOPs and processes, track important PV functions, and ensure inspection readiness.
This webinar discusses experiences in mitigating the challenges of recruiting and retaining patients, increasing efficiencies and stopping the "leaky" patient recruitment funnel
Watch our 90-minute educational webinar to gain an in-depth overview of pediatric NAFLD and get insights on developing strategies that help navigate today's challenging clinical trial landscape.
