Indian Society for Clinical Research
presents Virtual Symposium on
Submission standards for various Health Authorities for Statisticians & Statistical Programmers
2rd Dec 2022, 14:00 (IST) - 17:00 (IST)
Drug application submissions at global regulatory agencies such as the FDA, EMA, PMDA, NMPA and DCGI require well-defined data standards following the CDISC SDTM and ADaM specifications. In many companies, Biostatistics and statistical programming functions have become the data hub and provide regulatory-compliant data packages following these formats
The submission requirements vary across the regulatory agencies. It is more important for a Statistician or Statistical Programmer to understand the requirements and fulfill. This workshop is going to explore data submission package requirements for various global regulatory bodies. This four-hour workshop is designed to enable and explore the participants to gain more insights on submission requirements and differences between the agency’s requirements from Statistician’s & statistical programmers’ perspective.
Who should attend: Data Scientists, Statistical Programmers working with Pharmaceutical Industry or Contract Research Organizations, Biostatisticians, Medical Writers, Clinical Scientists, Clinical Data Managers, Investigators, Research Scholars or Scientists interested in Clinical Research, HealthCare Professionals from Government Agencies, Non-profit Organizations/Associations and Academia, and Medical, Pharmacy, Statistics or Life-science Students or Professionals interested in Clinical Research.
All registered participants will receive a “Certificate of Participation” from ISCR.