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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12th Project & Portfolio Management in the Pharmaceutical Industry Congress
12th Project and Portfolio Management Congress in Europe presents a high-level meeting looking at the best ways forward in enhanced R&D productivity, forecasting and ultimately, optimizing balance throughout the lifecycle.
Pharmaceutical Cold Chain & Logistics in Latin America
Join professionals from Latin America in a remarkable event that will be a step ahead in your professional career thanks the ultimate knowledge and insights shared in these two days.
5th Annual Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform to discuss compliance and transparency areas of key concern. Goal is to unravel compliance challenges, define and learn fair market value and develop a consistent, simple and transparent method and strategy for your company.
Interview: A holistic approach to the strategic planning process
Read the full interview with Ken Dobie, Founder & Principal of Skyemar Consulting, Former Director, Corporate Planning & Portfolio Management, Illumina and gain the insight into the aligning strategic priorities to portfolio management and associated resources.
Interview: East vs. West – Is there a regional approach to PPM in the US?
Read the full interview with Leigh Shultz, PhD, PMP, Associate Vice President, Project Management – Primary Care, Infectious Disease, Vaccines, Global Project & Alliance Management, Merck and gain insight into the regional approach to PPM across the US.
Interview: Project & Portfolio Management for Pharma & Biotech
Read the full interview with Eric Towler, Therapeutic Area Lead, BioPharma Project Management, Bristol-Myers Squibb and gain insight into the latest PPM trends.