The Sales & Marketing Effectiveness in Chemicals Forum will bring together industry leaders as well as experts responsible and deeply involved in sales and marketing strategies.
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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Advanced Protein Aggregation & Characterization
This training will focus on occurrence of particles in drug products, effects of protein aggregates, critical process and parameters. Attendees will gain overview of on utility and limits of predictive experiments, learn concerns from the authorities and relevant aggregation guidelines, and more.
CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters
Attendees will be introduced to comparability in biosimilar development, the analytical strategies of protein characterization of biosimilars, the structure of proteins, in vitro pharmacology and much more.
Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.
Hassle-free air shipments with data loggers – 100% IATA compliant
Shipping temperature controlled pharmaceuticals is a complex business, with many variables and multiple supply chain partners involved. When shipments are sent with data loggers, they are subject to specific IATA and Dangerous Good Regulations to increase security of air cargo shipments. These regulations have become stricter year on year and reached a new level in 2017.
5 Changes in Signal Detection Management
The European Medicines Agency, regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals. A safety signal is generally defined as information about a new or known Adverse Event that may have been caused by a medicine, where it is therefore necessary to conduct further investigation. Evaluation of safety signals plays a major role within pharmacovigilance. Therefore, it is vital for regulatory authorities to know the latest updates detailing the risks and benefits of medicines. The EudraVigilance database is an important source of information on suspected adverse reactions and signals.
Hazardous chemical waste and its impact on the environment
Discover more about production and threats that are caused by hazardous chemical waste.