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
*Offer only valid for webinars included in this
email and cannot be combined with any existing promotions.
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