• No travel expenses.
• Hear about the latest developments in the biopharmaceutical industry.
• Access diverse topics from anywhere in the world.
• Minimize time spent away from the office.
• Keep the entire team, department, or company up to date.
• Access past webinars through our catalog of archived webinars.

MARCH 15
CONDUCTING CLINICAL TRIALS IN INDIA-CURRENT UPDATE ON OPPORTUNITIES AND CHALLENGES

This webinar will present both the opportunities and challenges associated with
conducting clinical trials in India.

FEATURED TOPICS

• Therapeutic areas and indications in which current trials are currently ongoing in India
• Status of FDA inspections as well as FDA’s current objectives for their office in India
• Regulatory and logistical challenges
• How to ensure quality and compliance and minimize the likelihood of GCP violations
• FDA’s acceptance of foreign data as well as recent guidances on 1572s
• Investigator responsibilities and IRBs

MARCH 19
FDA-CDER DISCUSSES ACTIVITIES TO REDUCE PREVENTABLE MEDICATION HARM: REMS, MEDICATION ERRORS, AND SAFE USE

Hear FDA speakers discuss agency activities in the areas of REMs, medication errors, and the safe use initiative.

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

CONTACT
To suggest a topic or volunteer to organize a webinar, contact Colleen.Braun@diahome.org.