Press release: World Drug Safety Conference hears call for wider use of cognitive safety testing in drug development

April 30, 2015 In a call to the pharmaceutical industry at the World Drug Safety Conference in Chicago last week (April 22 to 23), a leading developer of cognitive assessment software, Cambridge Cognition plc (Cambridge, UK; LSE AIM: COG), stressed the increasing regulatory and clinical need to expand cognitive safety testing beyond CNS-targeted drugs. Speaking to an international audience of …

Whitepaper: A successful path to fulfilling pharmacovigilance obligations

White paper provided by Sciformix. Click here for more information  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. Among the multitude of challenges that face the global life science industry, the reduction in the number of new drug approvals has put …

Whitepaper: Proactive Pharmacovigilance

White paper provided by Sciformix. Click here for more information  21st century technologies will create significant opportunities and challenges for all health care stakeholders. Pharmacovigilance too is in transition, with new sources of medical information and methods for its analysis that will transform today’s largely reactive system into proactive benefit-risk management for all medication users. The discipline of pharmacovigilance (PV) largely originated in reaction to public …

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 …

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 …

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 …

Download: Proactive Pharmacovigilance – A New Model for the 21st Century

Whitepaper courtesy of Sciformix 21st century technologies will create significant opportunities and challenges for all health care stakeholders. Pharmacovigilance too is in transition, with new sources of medical information and methods for its analysis that will transform today’s largely reactive system into proactive benefit-risk management for all medication users. Download the Proactive Pharmacovigilance – A New Model for the 21st …

drug safety, insight, essentials, pharmacovigilance

Download: Essential Insights into Drug Safety

  Drug safety strategies are facing ongoing changes and developments as the pharma industry search for new and better ways of working and ensuring patient safety. The current transition from a reactive to a more proactive mind-set is being influenced by many things such as regulatory changes, patient awareness, new benefit risk standards, innovations in safety informatics and signal management …