Monday, April 1, 2013

Navigate Your Way to Success at the Largest Life Sciences Meeting in the Region - DIA2013

Navigate Your Way to Success at the
Largest Life Sciences Meeting in the Region

We want to make your DIA 2013 49th Annual Meeting experience a breeze. Navigating through more than 250 educational offerings across 22 tracks can be overwhelming to select the sessions that best fit your needs. We have provided a tailored schedule for Clinical Safety and Pharmacovigilance Professionals. We did the work for you!
What’s more, bring your colleagues or your whole team - divide and conquer - with so many exceptional sessions, spilt the sessions and benefit from more at DIA 2013 49th Annual Meeting. Contact our Group Discount Representative for details!
Don't miss out on this opportunity to meet with people from around the world, share your views and knowledge, network, and build new relationships with the greatest educational offerings under one roof.
Lead the Way to Expedite Products to Market!

Monday, June 24
Electronic Health Records (EHRs) in Signal Detection and Evaluation
11:00AM-12:30PM ET
This session will provide and in-depth update on various initiatives that have been launched worldwide to investigate the uses of electronic health records (EHRs).
Narrative Medicine and Pharmacovigilance
11:00AM-12:30PM ET
In recent years, pharmacovigilance has emphasized the collection and submission of tabular data. Using ideas from narrative medicine, we can re-focus on the patient’s story to better understand adverse drug reactions and Benefit-risk balance.
European Town Hall: Implementation of New Safety Legislation and Other Hot Topics
11:00AM-12:30PM ET
Get the first experiences with the new PRAC and how the PRAC interacts with the different EU committees (such as the CHMP and CMDh).
The New Standards for the Identification of Medicinal Products and Individual Case Safety Reporting Applied in Pharmacovigilance
2:30-4:00PM ET
The development of the international standards arising from the International Conference on Harmonization (ICH) are close to finalization and implementation. Hear about the status of the two related projects from an EMA and FDA perspective and the industry response to this work.
Characterizing Drug Shortages and Their Causes: Anticipating Future Trends
2:30-4:00PM ET
This session includes information on a 2012 study highlighting where and why drug shortages occur, as well as the impact of other forecasted drug development and commercialization trends.
Tuesday, June 25
Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting
8:00-9:30AM ET
Recommendations are presented from projects of the CTTI exploring expedited safety reporting for clinical trials, and aligning regulatory practices for reporting with statistics and patient expectations.
Social Media, Mobile Applications and Patient Support Programs: Challenges and Solutions for Handling Drug Safety Information
8:00-9:30AM ET
Discuss pharmacovigilance implications including adverse event handling and risk mitigation solutions from the regulatory and drug safety point of view.
Big Data: Impact on Innovation
10:15-11:45AM ET
Examine pharma, safety, and patient perspectives on big data and the need for real-world examples.
EU Update: PROTECT and EnCePP
10:15-11:45AM ET
Learn about PROTECT, which aims to develop and validate innovative methods for Benefit-risk assessment of medicine
Periodic Reporting in Drug Safety: From Safety Updates to Continuous Signal Monitoring and
Benefit-Risk Evaluations

1:45-3:15PM ET
The session will present the new structure of PSURs/PBRERs according to the GVP/ICH E2C(R2) guidance. Requirements and challenges will be outlined.
Quality Assurance for Signal Detection Programs
1:45-3:15PM ET
New EU legislation requires quality assurance of critical safety processes, including signal detection. This forum will discuss the best practices for a signal detection program.
Risk Management in the US, EU and Japan: The Challenges of Diversity
4:00-5:30PM ET
This interactive forum will discuss the differences in legislation and the challenges of risk management planning in the United States, Europe, and Japan.
Wednesday, June 26
Molecular Predictors of Drug-induced Harm: From Clinical Development to Postmarketing Surveillance
8:00-9:30AM ET
This session will describe opportunities to identify molecular predictors of drug-induced harm in clinical development and postmarketing surveillance.
Pharmacovigilance Update for Japan, Developing Asia and Latin America
8:00-9:30AM ET
Review the current status of pharmacovigilance and provide suggestions on how to meet reporting requirements and working with licensing partners and affiliated companies in Japan and the developing world in Asia and Latin America.
An Interactive Course on Likelihood Ratio Test-based Method for Signal Detection
1:45-3:15PM ET
This workshop will provide an overview of the likelihood ratio test-based signal detection method for FDA’s AERS database, as well as a demonstration of the (LRT) tool.
TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology
1:45-3:15PM ET
Learn about the methodology developed by TransCelerate members for quality risk management and risk-based monitoring implementation.
Herbal-induced Organ Toxicity (HILI): How That May Impact Rx Benefit-risk
4:00-5:30PM ET
Discuss the role of natural health products in risk assessment and the importance of the internal review process.
Developing a Patient Aid to Make Information about Treatment Benefits, Harms and Uncertainties Meaningful to Individual Patients and Enhance Their Decisions
4:00-5:30PM ET
The session will: 1) raise awareness across the decision-making health community about recent drug regulatory science innovations driving a patient-focused approach; and 2) be a springboard to trigger further engineering of applications for these trends for use across the community.
Thursday, June 27
Tracking Misuse and Abuse of Marketed Products: Is Pharma Doing All that It Can?
9:00-10:30AM ET
This session will focus on the best practices involved in monitoring, tracking and reporting off-label use and misuse and abuse of pharmaceutical products.
Coding with Confidence
9:00-10:30AM ET
You will apply the key principles of the “MedDRA® Term Selection: Points to Consider” document by engaging in practical coding exercises in an interactive format.
Off-target Blood Pressure Changes and Evaluation in Drug Development: Safety,Clinical and Regulatory Considerations
10:45-12:45AM ET
Gain insight into the “off-target” BP response of drugs outside of cardiovascular drugs from a development and regulatory perspective.
Sunday, June 23 Preconference Tutorials
Kick off the week by extending your education prior to the start of the Annual Meeting. Register for two half-day tutorials or one full-day tutorial and SAVE $100 on of your Annual Meeting registration.
Risk Communications
9:00AM-5:00PM ET
Analysis of Safety Data from Clinical Trials
1:00-4:30PM ET
Highlights of the New Pharmacovigilance Legislation in the EU: Key Points to be Taken into Account for Successful Implementation and Lessons Learned
1:00-4:30PM ET
Keynote Speaker Hotel & Travel Exhibiting
Daniel Kraft, MD
Executive Director, FutureMed
Book within the DIA Room Block,
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