According to the new draft Drug Safety Guidance for Industry, Biopharmaceutical and Devices companies are urged to consider utilizing Safety Assessment Committees (SAC) in assuring compliance and monitoring, as well as reporting the pertinent safety data throughout a drug”s development program and beyond. This is especially critical in regards to the products with significant life cycle plan.
Improve patient safety, as it would utilize a more structured, proactive, and comprehensive fashion of a reporting method, supplementing IND through NDA, and beyond.
The FDA”s “Newly Added Documents” repository produces a proper road map to lay the groundwork in the construct of the practices across therapeutic areas.
It is sure to detect, mitigate, and potentially add to the ongoing surveillance plans, as a critical tool.
GAP”s SAC includes a therapeutic leader in the indication of the product, specialists across the specific Therapeutic Areas (TAs) as needed, a core MD/Safety Lead which allows regular and ad hoc meetings. It may be structured as an internal, external (as highly recommended by FDA), or both, as needed. Its compliance is priceless.
SAC is entirely different than a traditional Data Monitoring Committee (DSMB). It is distinctly different, as it may be facilitated by the use of the DSMB”s findings. SAC is separated from the unblinded and/or the efficacy data.
GAP will establish the Standard Operating Procedure (SOP), provide the structural foundation, and operate the SAC internally or externally, as needed.
GAP has the knowledge, hands on experience, and proven track record in establishing and operating SACs, in an effective and extremely cost-effective manner.
Practical approach to establishment of SAC:
Cost containing measures to avoid sending an avalanche of unnecessary SUSARs (over 30% reduction in the process, as the core pharmacovigilance skills are utilized).
Cost mitigation in risk management throughout the life of a product, including its life cycle management into ongoing and rolled out clinical trials beyond the primary launching of IND-NDA/BLA.
First hand, and effective communication associated with the observed risk profiles. Neither the unblinded data, nor the efficacy report, is going to prejudice its efforts. A clean and focused safety report is provided. Early detection and proper economical mitigation is priceless.
Compliance with the guidance. It is a must as time is moving forward.
Why GAP for SAC?
More than 14 years of experience in all aspects of Global Pharmacovigilance and Epidemiology
A strong,proven data, based on the successfully established and ongoing SACs, to assure a financial translation to all cost containing measures
Access to the best and brightest in the TA, and Specialty leadership.
A skilled staff of epidemiology as well as strategic and conventional algorithm analysts in technical/biostatistical analysis, defined structural programming of IT/CDM, as well as epidemiological formations.
Well known and reputed by the health authorities including FDA and EMA.
Contact us for more information.