If you would like to submit a proposal for an oral or poster presentation at this
meeting, please click the 'submit abstract' button to view the information required
for your submission.
When ready just return to this page and fill out the form accordingly.
All abstracts will be reviewed by the Scientific Advisory Board and applicants will
be notified of the result in due course.
Successful applicants will be provided with all necessary information.
Abstract Content:
- Written in English
- Written in the third person
- Include title, name(s) and affiliation(s) of the authors
- Between 100 - 200 words
- Suitable for direct publication in the proceedings pack and on the website
- Related to the subject of the conference
Agenda Topics- Computers, IT, Electronic Data Management & Archival Systems
- Calibration, Validation, 21 CFR Part 11 compliance, Archival and Back up
- CRO Audits-Vital Requirements & Audit Points
- Case study, Issues, Suggestions and Solutions
- Managing Unannounced Audits
- CRO Showcase
- CRO/Sponsor - Bridging Gaps
- Elements of Master Service agreement
- Roles, Responsibilities, BE-NOC Approvals
- Ensuring Data Integrity in Clinical Study
- Role of IT personnel in data integrity
- Significance, Issues and Challenges
- Training, Verification and Audits
- Ensuring Successful BABE Studies in Light of Regulatory Requirements
- Discriminatory dissolution profile benchmarking vis a vis BE response
- Ensuring Pivotal BE study outcome while benchmarking Pilot BE study
- Success rate of Pivotal BABE study
- Evolving US/European Markets and CT/GCP Guidelines
- Regulatory and QA Perspective in Pharma and Clinical Research
- Indian CRO - Issues, Challenges and Possible Solutions
- Regaining and Retaining Integrity
- Volunteer Cross Participation
Copyrights
The presenting author/person who submitted the abstract assumes full responsibility
of the content of the abstract and we assume that all co-authors are aware of this
content. Please note that your biography, summary and abstract may be used on this
website and conference materials.
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