UBC's Blog

UBC is committed to sharing ideas & insights with the pharmaceutical & biotech industry to address the full product lifecycle & support the development & commercialization of safe & effective products.

 

Real-Time Data from Long-Term Studies
Aaron Berger, PMP, Sr. Project Director - April 06, 2017
Registries are critical to demonstrating long-term safety, effectiveness, and value. These observational studies are a cornerstone of post-marketing research. However, by their very nature, extended studies create an information void...
Our EU risk management experts provide insights on the new EMA guidance.
Janine Collins, MBBS, LLM, Sr. Director, European Risk Management, and Dafna Bonneh-Barkay, PhD, MSc, Sr. Project Manager - April 03, 2017
Introduction On Friday, 31 March 2017 the EMA released the revised Module V- Risk Management Systems (Rev 2) of Good Pharmacovigilance Practice (GVP) (EMA/838713/2011 Rev 2) accompanied by a revised Guidance on the format of the...
Leo Tysak, Executive Director, Global Regulatory Compliance - March 31, 2017
Much of my team’s day-to-day responsibilities come down to planning: planning for good quality assurance practices, planning in case of a regulatory inspection, planning responses to questions during an inspection, and even planning...
Nurses support autoimmune patients
UBC - March 16, 2017
Approximately 50 million Americans, or one in five people, have an autoimmune disease. In these patients, the immune system attacks healthy cells by mistake. These diseases, more than 130 known at this time, can affect many parts of...
NIH Rare Disease Day 2017
Shazia Ahmad, Director, Patient & Physician Services, and Bonnie Le, Sr. Coordinator, Patient & Physician Services - March 09, 2017
Each year since 2009, the National Institutes of Health (NIH) Clinical Center and National Center for Advancing Translational Sciences (NCATS) has hosted Rare Disease Day at NIH to participate in the global observance. This year, we...

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