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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
April 10, 2017
Pharmaceutical Technology spoke with CPhI North America presenters Ben Locwin, PhD, MBA, MBB, president at Healthcare Science Advisors, and Tom Fox, principal at Advanced Compliance Solutions, to discuss drug pricing, compliance challenges, and corporate social responsibility in the bio/pharmaceutical industry.
April 07, 2017
A drop in US drug approvals was noted but this trend was not yet seen in Europe.
The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.
April 06, 2017
The role of patient advocates in shaping regulations and policy has put attention on financial and operational links between drug companies and independent health organizations.
FDA is in the center of the debate over developing and pricing new cancer therapies.
A new study in NEJM compares the regulatory review processes of FDA and EMA.
April 05, 2017
What are the pros, cons, and practicalities of moving pharma manufacturing back to the US? \
Scott Gottlieb answers Senators' questions at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.
Deutetrabenazine is the first deuterated product approved by FDA, approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a decade.
April 04, 2017
EMA has developed a framework and action plan to foster relationships with the academic community.