A Regulatory Affairs Course with Comprehensive & Interactive Discussions on:
Guidance and Requirements for ANDA/ANDS Approval
Brand versus Generic Legal Issues
Trade Dress Requirements
European Registration System for Generics
Impact of New EC Laws on Data Exclusivity
INDIA and CHINA - Emerging Generic Strategies
How to Submit a Quality Dossier to Reduce Approval Time
The 505(b)(2) Application and Approval Route
Forfeiture of 180-day Exclusivity
Legal Challenges to the 505(b)(2) Process
Labeling Requirements for ANDA/ANDS Approval
Post-Approval Reporting Requirements for ANDA Amendments
Field Alerts and Deviation Reports
The DMF Filing as Part of the Drug Submission
Workshop:
Preparing a Regulatory Submission in CTD Format
Information to be posted shortly
Information to be posted shortly
This two day conference is directed towards Directors, Managers, supervisors, and Associates in the Pharmaceutical, Biopharmaceutical and allied industries with responsibilities in:
Regulatory Affairs
Quality Assurance
Drug Development
Submissions
Product Registration
Product Development
Project Management
Clinical Research
Compliance
Documentation and Technical Writing
Electronic Submissions
Training
Registration opening soon
Please contact us for more information, you may fill in form below.
Thursday September 9, 2010
