Over the past five years, the cosmetic industry has met with several legislative changes. Within the new legislative package, including the new REACH and CLP, it is important to find a comfortable routine that will minimize costs while staying effective and compliant with all regulations.
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.
Driving the national agenda of Medical tourism through PX Excellence
Read the interview with Dr. Layla Al-Marzouqi, Director of Medical Tourism Council at Dubai Health Authority, and learn how to enrich patient experience and quality of healthcare.
No more trouble with dangerous good shipments
Global temperature controlled pharmaceutical shipments are constantly faced with new logistics challenges and regulations. This January 2017, IATA Dangerous Goods Regulations added further complexity to shipping cold chain products compliantly.
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.