benefit risk, quantification, pharma, Drug Safety

Implementing benefit-risk thinking and quantification into the culture and processes of a large pharmaceutical company.

At the 2014 World Drug Safety Congress Americas Susan Duke, GSK, gave a presentation on “Implementing benefit-risk thinking and quantification into the culture and processes of a large pharmaceutical company.” Download and learn: Benefit-Risk thinking and quantitative evaluation at GSK How it began Where we are now Keeping it simple (unless it’s complex) What are the right questions? Where is …

Pharmacovigilance, Inspections, trends, drug safety

Pharmacovigilance Inspections: Trends and Tools.

At the 2014 World Drug Safety Congress Americas, Daniel Tripp, Pfizer, gave a presentation on “Pharmacovigilance Inspections: Trends and Tools.” Download and learn: Pharmacovigilance Inspection Trends Pharmacovigilance Inspections Preparation Tools Pharmacovigilance Inspections Responses and Follow up Download Presentation. Found this interesting? Join us in 2015 for the 7th annual World Drug Safety Congress Americas conference. The conference will address improving …

PRA whitepaper, sponsor and cro pharmacovigilance, alliances

Whitepaper: Sponsor & CRO Pharmacovigilance Alliances

Outsourcing pharmacovigilance activities is a standard business practice in a rapidly expanding market segment. In the past, outsourced safety services were limited due to concerns about confidentiality, data security and liability in cases of regulatory non-compliance, which are all still important considerations today. Because of the changing industrial and regulatory environment, sponsors are re-evaluating the advantages and disadvantages of outsourcing their pharmacovigilance obligations. With stricter …

New EU, Vigilance Practices, Legislation, Drug safety

New EU Good Vigilance Practices Legislation

At the 2014 World Drug Safety Congress Americas, Mariska Kooijmans, Biogen Idec, gave a presentation on “New EU Good Vigilance Practices Legislation.” Download and learn: Background and goals EU PV Legislation EU GVP Modules – major changes PRAC PV Quality Requirements Pharmacovigilance Systems Master File (PSMF) Biogen Idec approach to implementation Summary Download Presentation Found this interesting? Join us in …

Ebook: Your Drug Safety Guide on how to sustain transparency in pharmacovigilance

Drug safety is evolving in these exciting challenging times. As organisations embrace a proactive drug safety culture, emerging technologies are coming to the forefront of pharmacovigilance and are performing an increasingly strategic function. Ongoing developments in the regulatory environment, signal management and technologies are bringing the patient to the fore. How do you sustain patient centric pharmacovigilance? Where can we improve? How do we manage …

Regulatory Changes, Implications, Drug Safety

Global Regulatory Changes and Resulting Implications On Drug Safety

At the 2014 World Drug Safety Congress Americas, Bruce Donzanti, Genentech inc, gave a presentation on “Global Regulatory Changes and Resulting Implications On Drug Safety”. Download and learn: Recent major global Drug Safety Regulatory Changes Differences and Bridging the Gaps Health Agency Perspective on Solicited Programs CIOMS V: Concept of Incidental Data Solicited Programs: Volume and Interactions A Risk-Based Approach …

Technology, Signal detection, understanding, drug safety

Technologies to Improve Signal Detection and Understanding

At the 2014 World Drug Safety Congress Americas, Dr. Akhilesh Sharma, Dr Reddy’s laboratories ltd, gave a presentation on “Technologies to Improve Signal Detection and Understanding”. Download and learn: Background and Rationale Practical Signal Management Innovation and Enhanced Signal Detection Technologies for Signal Detection Download Presentation. Found this interesting? Join us in 2015 for the 7th annual World Drug Safety …

New Benefit- Risk, PSUR, Benefit-Risk Assessment, drug safety

New Benefit-Risk PSUR: Impact on Benefit-Risk Assessment

At the 2014 World Drug Safety Congress Americas, Anne Wolka, Eli Lilly and Company, gave a presentation on “New Benefit-Risk PSUR: Impact on Benefit-Risk Assessment”. Download and learn: The rebirth of the PSUR Objective of the PBRER Critical Analysis of Benefits Critical Analysis of Risks Integrated Benefit-Risk Analysis Impact of the PBRER So What Is a Structured Approach to Benefit-Risk Assessment? …

Download: The New Frontier for the Pharmaceutical and Life Sciences Industry- Real Big Value from Big Data

  Technological growth and easy access to sophisticated gadgets have led to a digital data explosion. The life sciences industry is no exception, with its top priority being to improve the quality of human health and well being. Big Data helps achieve this by leveraging innovative techniques to enhance productivity in R&D, and reducing the cycle time for drug development …

Download: A successful path to fulfilling Pharmacovigilance obligations

  As the number of innovator pharmaceutical and generic manufacturer partnerships grow, the lines of responsibility for meeting pharmacovigilance requirements can get blurred. This whitepaper looks at routes to managing the issue. Download the whitepaper to learn: Imperatives to consider when adopting a model for PV outsourcing due to global expansion Big pharma/generics partnerships Managing pharmacovigilance Defining the roadmap: a case study Critical …