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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Process Scale-Up in Pharma (Solid Dosage Forms)
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.
Patient Adherence and Engagement
Discuss the issues of non-adherence with other stakeholders and find a solution together with the patients themselves.
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.
Turning Patient Feedback to Meaningful Resource for Care Delivery
Read the interview with Nasser Al Naimi, Deputy Chief Quality Officer at Hamad Medical Corporation, and Co-Director at Hamad Healthcare Quality Institute, and learn how to turn your data into strategic information to drive patient-family centered care.
Creating & Leading Patient Experience Excellence
Read the full interview with Dr. Ahmed Mohammad Abu-Abah, CEO at King Abdullah BinAbdulaziz University Hospital and gain insight into the creating & leading patient experience excellence.
Excelling in PV is not only about Technical Expertise
For a PV leader, to be successful can look like a daily Herculean work: meeting a crucial mandate to minimize harm to patients, while ensuring that a product is prescribed to the right population, and maintaining the highest level of compliance within a very complex set of worldwide regulations.