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MARCH 30
eCTD 101: AN OVERVIEW AND ITS IMPACT ON THE REGULATORY SUBMISSIONS PROCESS
This webinar will provide a basic overview of the structure and content of the eCTD and address technical issues related to its implementation
across process areas.
FEATURED TOPICS
- Basics of eCTD compilation
- Impact of eCTD on authoring environment
- Submission management and impact on work-flow and process
- Regulatory differences between US, EU, Canada, and Japan
MARCH 31
CASE PROCESSING AND SIGNAL DETECTION: BUSINESS PROCESS OPTIMIZATION IN PHARMACOVIGILANCE
Learn how to identify and assess areas that need improvement and present strategies for implementing business processes related to case processing (pre- and post-NDA approval) and signaling.
FEATURED TOPICS
- Why you need to understand and improve your pharmacovigilance processes
- Reference case processing and signaling process models
- Key differences between improvement and optimization
- Classic approaches to and monitoring and simulation of process analysis and optimization
- Global and local processes
- Change management
- Metrics
- Supplementing the workforce
APRIL 8
FDAAA AND REMS: TWO YEARS AND COUNTING
This webinar will examine the impact of FDAAA and REMS since they became effective in March of 2008, analyze the cumulative experience of two years from a broad perspective, and will present and evaluate REMS implementation issues. The presenters will also include an update on discussions surrounding class REMS, which could have a far-reaching eff ect on future REMS developments.
FEATURED TOPICS
- Updates on recent REMS approvals, including an evaluation of REMS elements required
- REMS implementation issues, such as monitoring, assessments, working with third parties, and labeling changes submitted through
- CBE (Changes Being Effected)
- Class REMS considerations and current status
- Overview of the REMS Draft Guidance Document, including public comments to the docket
APRIL 20
SAFETY REPORTING REQUIREMENTS IN CLINICAL TRIALS: INDIAN AND EUROPEAN PERSPECTIVES
This webinar will explore the key diff erence between essential safety regulatory requirements in India and Europe as well as the various challenges associated with pharmacovigilance of global clinical trials.
FEATURED TOPICS
- Regulatory requirements for expedited reporting in clinical trials
- Requirements for annual reports
- Challenges and special situations associated with safety management in clinical trials from Indian and European perspectives
APRIL 22
UPDATE ON AMCP FORMAT VERSION 3.0: INDUSTRY PERSPECTIVE
Review changes made in version 3.0 and discuss their implications for health care systems and pharmaceutical and biotech manufacturers.
FEATURED TOPICS
- History of the AMCP format and revision process
- Summary of the revisions
- Updated guidance on product dossier content development for manufacturers
- Specific clinical and economic evidentiary requirements by health plans and other payers
- Implications of the AMCP dossier on the unsolicited request process
CONTACT
To suggest a topic or volunteer to organize a webinar, contact Colleen.Braun@diahome.org. |