Pharmacovigilance and Risk Management Strategies Conference

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DIA’s Pharmacovigilance and Risk Management Strategies Conference [1] is the leading forum for exploring insights into new technologies and innovative methods and how they can be utilized for pharmacovigilance in the broadest sense. This year’s program focuses deeply on cutting edge innovation across the entire life cycle of biopharmaceutical products including new therapeutic approaches to diseases that change patients’ lives, enlightened evolution of regulatory science that speeds needed products to prescribers and patients, and, most importantly, engagement of patients in the product development and regulatory processes.

Learning Objectives

At the conclusion of this conference, participants should be able to:

• Employ the current regulatory framework for pharmacovigilance in key markets, including the US and EU.

• Examine the influence of recent regulatory developments and expectations in Japan, China, and Mexico on safety and pharmacovigilance practice.

• Discuss how advanced therapies and technologies may impact pharmacovigilance and risk management.

• Discuss how the needs for access to innovative medicines and for safety information can be balanced during the application of new adaptive development pathways.

• Describe considerations for appraising the value of data sources outside the spontaneous reporting system for safety and benefit-risk assessments.

• Utilize new approaches for presentation of benefit-risk data and communication of risk-benefit messages to health care providers, patients, and consumer.


PV organizations have now fully embraced outsourcing services to external vendors, either partially or completely. In the last three years, organizations have not only looked to move systems to the cloud but also to accelerate the externalization of some of the heavy lifting required by the regulations. PV departments currently want to find the lowest cost to process individual case or expedited reports, regardless of vendor actions. As long as the vendor passes the audits and can deliver consistent quality and turnaround times, cheaper is better. [2]

The main driving force is the budget, of course, but an increase in incoming adverse event (AE) reports is forecasted due to multiple factors: [2]

• We are in a new era of medical breakthroughs that will result in new expressions of side effects.

• There are new sources for AE collection, from more specific market programs to in-house pharmacies or social media.

• There are new regulatory expectations in terms of transparency and patient advocacy involvement/relations.

• Safety objectives are required earlier and earlier in pipeline development (pre-clinical safety).

Selected Tweets

Date Author Tweet
Feb 2, 2017 Brian Overstreet Great read from @AdveraHealthJD on #PVRMS17 [2]
Jan 23, 2017 Michael Cipriano Not exactly "FDA Updates". More like a repeat of a presentation from over a month ago #PVRMS17: [3]


  2. 2.0 2.1

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