Event Calendar 2019
PSI Scientific Committee Webinar: Statistical Challenges in Analytical Comparability and Biosimilarity Assessment
15 Oct 2019
This webinar will discuss statistical requirements for the assessment of analytical comparability and similarity assessments, for example between biosimilars and reference products or before and after manufacturing changes. This topic has been the subject of a recent EMA reflection paper and an EFSPI working group. New strategies are proposed as an alternative to mean comparisons and include the assessment of ranges, inferential approaches or the use of Bayesian methods.
Deep dive into Regulatory submissions – role of Programmer / Statistician
Ramee Grand Hotel, Pune
18 Oct 2019
Regulatory submissions are very important milestones for pharmaceutical organizations/sponsors post completion of analysis and reporting of any clinical trial that documents the safety and efficacy data of their new innovative medicinal products. In order to accelerate and shorten the time from lab to market and bring clinical benefits to patients faster, while ensuring patient safety and optimizing research investments, we require quality regulatory submissions. This would also speed up regulatory agencies’ review, evaluation and approval of new products. eCTD (electronic Common Technical Document) is a standard required format to submit all the clinical research and development data of a new investigational product to the Health Authorities. In addition to individual clinical study reports, sponsors require to pool safety and efficacy data from individual clinical studies, prepare, and submit Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports into CTD for product benefit-risk evaluation. After a regulatory submission, there are usually Health Authority Questions (HAQs) on data and sponsors may need to explore/investigate individual or pooled study data, reports and provide responses quickly back to the HA. After review of submitted dossier, the HA may decide to further evaluate the product through Advisory Committee (AdCom) meeting discussions before their decision on product approval. Sponsors may have to prepare additional exploratory analyses for any potential questions from the AdCom meetings. For any regulatory submission, statistical programmers and statisticians play key roles in the preparation of the submission deliverables and also planning and generating ISS/ISE reports, responding to HA questions and performing exploratory analyses for AdCom meetings. This workshop will aim to discuss various statistical activities required for regulatory submissions in multiple therapeutic/disease areas with case studies/examples, including roles and responsibilities of statisticians and statistical programmers. This will also delve into common challenges in planning and generating the reports including electronic submission requirement per CDISC compliance.
Conference for Statistics and Programming in Clinical Research(ConSPIC)
Radisson Blu Resort, Cavelossim Beach, Goa, India
13-15 Nov 2019
The 10th edition of ConSPIC will be held in Goa in November. Visit the ConSPIC 2019 page for more information.