Exclusive Offer to DIA Members: Register for Two Webinars and Save $250.

Exclusive Offer to DIA Members: Register for Two Webinars and Save $250. Busy life sciences professionals need affordable, convenient, and immediate access on the latest developments in the ever-changing health care industry. DIA webinars offer just that - access to timely and authoritative information. Take advantage of this special offer. Offer ends October 18. Check Out These Hot Topics: The Current State of Quality Oversight in the Pharmaceutical Industry October 9 | 11:00AM-12:30PM ET With definitions remaining unclear as to what, exactly, quality oversight (QO) should entail and how optimal quality oversight programs can be effected. This webinar will provide a definition of QO and delve deeper into the state of QO today. Connecting the Right Sites to Promising Trials: The Role of Web-based Feasibility Assessment October 23 | 11:00AM-12:30PM ET This webinar will address common weaknesses in the established process of feasibility assessments and site selection, from the point of view of both trial planners and research centers. The speakers will review relevant key performance indicators (KPIs) and how to address them, global country selection strategies, and better management of site feasibility assessment. FDASIA Year in Review October 24 | 11:00AM-12:30PM ET Hear what FDASIA has given us this past year – and what we might expect in the coming year. This webinar will focus on the progress of the PDUFA V and initiatives to promote innovation and speed to patient access covering: user fee levels, perspective on the new molecular entity review process, status update on Benefit-risk assessment activities, and FDA’s interpretation of the fast track, breakthrough therapy, accelerated approval, and priority review programs. CDER Town Meeting: Safety Hot Topics October 30 | 2:30-4:00PM ET In this interactive webinar, participants will submit questions regarding safety to senior leadership from the US FDA Center for Drug Evaluation and Research through an anonymous, computerized Q&A function. CardioVascular Safety: The New Paradigm - Proarrhythmic Assessment of New Drugs Without the Thorough QT Study October 31 | 11:00AM-12:30PM ET Explore the current approach to assessing the possible proarrhyrhmic potential of drugs and its strengths and weaknesses, a new paradigm that relies more fully on preclinical testing and its advantages and challenges, and key regulatory issues surrounding implementing a new paradigm. CardioVascular Safety – What are the Key Issues Regarding Blood Pressure Assessment During Clinical Development November 7 | 11:00AM-12:30PM ET Explore the current approach to assessing the possible proarrhyrhmic potential of drugs and its strengths and weaknesses, a new paradigm that relies more fully on preclinical testing and its advantages and challenges, and key regulatory issues surrounding implementing a new paradigm. Aligning the Voices of Change in the Health Care System November 12 | 11:00AM-12:30PM ET Several legislations have been introduced calling for regulatory reform in the health care process. FDA is under pressure from industry to enable a regulatory framework for translational medicine but at the same time preserve the public health. This 90-minute webinar will show how important it is for the patient voice to be included when these legislations are drafted. More Upcoming Webinars: Practical Aspects and Examples of Using Large Datasets for Identifying and Investigating Product Safety and Effectiveness in the US and EU November 18 | 11:00AM-12:30PM ET The Case of the New England Compounding Center: Learning from the Tragedy November 19 | 11:00AM-12:30PM ET Social and Collaborative Tools in Regulatory Intelligence November 21 | 11:00AM-12:30PM ET Electronic Submissions 101 – Essential MS Word and Adobe Acrobat Tools/Skills and Current IT Options December 4 | 11:00AM-12:30PM ET Combination Products and Convergence: An Overview of Clinical Benefits, Regulatory Issues & Manufacturing Challenges December 5 | 11:00AM-12:30PM ET Global Overview - Economic Power in Asian Countries December 11 | 11:00AM-12:30PM ET View the Full List of Webinars for Complete Details *Offer only valid for webinars included in this email and cannot be combined with any existing promotions.

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How does Risk Communication differ in US and EU?

Risk Communications
June 23 from 9:00AM – 5:00PM in Boston

This tutorial teaches risk management best practices to optimize medical product safety. Participants will learn proven strategies to improve product safety, maximize patient benefits and minimize risk.

Instructor(s):
Nancy D. Smith, PhD
Adjunct Professor at Temple University
FDA Alumni, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.