The major objective of this course is to provide a detailed insight into the practical aspects and approaches of process scale-up for different unit operations and technologies.
Whitepaper: Detection and Management of Safety Signals
What defines a signal? Why do we need to do signal detection and what steps are involved? Although signal detection can take many forms, there are basics to the process no matter where you market your products.
The FDA Guidance for Industry entitled Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (from March 2005) is the reference most commonly used by companies marketing pharmaceutical products in the U.S. This guidance evolved from one of three papers delivered by the FDA as part of PDUFA III which resulted from public comment on risk management for regulated drugs. As stated, the guidance is not intended for all products but focuses on products which may pose a clinically important and / or unusual type or level of risk. The guidance is also geared towards the post-approval period of a product. The FDA defines a safety signal as a concern about an excess of adverse events compared to what would be expected to be associated with a product’s use. The FDA is clear that the topics presented in the guidance are in-line with international discussions as well ...
Read more in the downloadable whitepaper by Robin Williams, B.S., CMC, Senior Safety Scientist, Ashfield Pharmacovigilance.
In case you are interested, find out more useful information in case studies.
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Targeted Drug Delivery
Gain detailed overview of the newest strategies in drug delivery and targeting.
Next Generation Antibody Therapeutics
This focused 2-day training will cover the discovery, engineering and production of next-generation antibodies, antibody fragments, bispecific Abs, innovative ADCs and more. Follow the path from their discovery and selection through engineering and expression to production and regulatory issues.
White Paper: Beyond the Cold Chain
Take a Good Look at the Future of Corporate Universities
There are four things corporate universities can do to avoid becoming irrelevant in the digital age.
Ready for the new GCP ICH E6 (R2) addendum?
On the 23rd of July 2015, the EMA's Committee for Human Medicinal Products released the Guideline for Good Clinical Practice E6(R2) for consultation. On the 14th of June 2017, it will come into effect and influence everyone involved in the clinical research process. What does it mean to pharma and biotech companies, sponsors, CROs, research institutes and third-party organizations?