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Past Events 2020
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Feb
27
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R workshop
With the advancements in technology the industry is slowly moving towards newer and different programming languages and environments. R is one such language and environment that is slowly emerging as a tool of choice for statistical computing and graphics. Many companies are also considering R as an alternative tool that can be used for validation of statistical analysis and can also be used for clinical trials’ submission driven work. R is very similar to the S language that was developed by Bell Laboratories and is used by statisticians and programmers for Statistical Analysis and computing, owing to its wide array of available statistical techniques such as linear and nonlinear modelling, classical statistical tests, time-series analysis, classification, clustering, etc., and graphical techniques. R is used widely both in academia and industry, including the pharmaceutical industry. This workshop will help users to understand basics of R and at the end of the workshop, users will be able to appreciate the uses and versatility of R and how it can be used for statistical analysis in clinical trials.
Feb 27 2020 | Lemon Tree Premier, Hi-Tec City, Madhapur, Hyderabad, Telangana 500081
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Feb
13
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PMDA e-submissions: Expectations and Experiences - An IASCT Social Event
An overview of PMDA e-submissions, expectations and requirements and experience sharing by one of the industry experts - Takashi Kitahara.
Feb 13 2020 | PAREXEL International, Building No.20, 11th Floor, Raheja Mindspace IT Park, Madhapur, Hyderabad, Telangana, INDIA– 500 081
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Past Events 2019
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Nov
29
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IASCT Academic Connect - Loyola College Chennai
The objective of the IASCT Academic Connect is to create a platform to interact and discuss on the role of statistics and programming in drug development. The event is expected to create dialogue between Academia and Pharmaceutical industry on the opportunities for students from Statistics, Computer Science and Life Sciences disciplines and professional skills required for data analytics in Pharma industry. The event also intends to provide a platform to develop academic and industry partnerships in clinical research, innovation and pedagogy.
Nov 29 2019 | Loyola College Chennai
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Nov
20
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Data Science at work: Stories from our consulting practice - An IASCT Social Event
The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety of information sources combined with the ability to store vast quantities of diverse data, but how do we make sense of it all? Sophisticated computational techniques have been developed to analyze data, but unlocking its full value requires gaining deep insights into the right questions. This talk will present a few case studies from the speaker's consulting practice and expertise in experimental design and data analytics, illustrating how answering the right questions matters most, and that statistical modeling techniques remain at the heart of data science. This session is the first Social Event being organized by IASCT and hosted by Cytel Statistical Software & Services Private Limited. This fast paced 45 minute talk session followed by a time of interaction is a great opportunity to network and connect with industry experts.
Nov 20 2019 | Cytel Statistical Software & Services Private Limited
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Nov
13
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Conference for Statistics and Programming in Clinical Research(ConSPIC)
The 10th edition of ConSPIC will be held in Goa in November. Visit the ConSPIC 2019 page for more information.
Nov 13 2019 | Radisson Blu Resort, Cavelossim Beach, Goa, India
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Oct
18
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Deep dive into Regulatory submissions – role of Programmer / Statistician
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.
Oct 18 2019 | Ramee Grand Hotel, Pune
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Oct
15
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PSI Scientific Committee Webinar: Statistical Challenges in Analytical Comparability and Biosimilarity Assessment
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.
Oct 15 2019 | Webinar
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Aug
08
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Study designs in Oncology and programming perspectives
This workshop aims to discuss on statistical considerations in different study designs and analysis of Oncology clinical trials and statistical programming concepts and application specific to Oncology trials data reporting, starting from the database to generation of analysis datasets and statistical reports. The focus will also be on areas in which the methodology is adapted in order to integrate with new approaches of therapeutic intervention.
Aug 08 2019 | Hotel St. Mark's, Bangalore
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May
08
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Webinar MCP-Mod – Theory, Implementation and Extensions.
MCP-Mod (Multiple Comparisons & Modelling) is a popular statistical methodology for model-based design and analysis of dose finding studies. This webinar will describe the theory behind MCP-Mod (plus extensions), and how to implement it within available software. Pantelis Vlachos (Cytel) will provide a brief introduction to the methodology and illustrate the MCP-MoD capabilities in EAST 6.5. Saswati Saha (Inserm, Aix-Marseille University) will discuss new variations and alternatives to MCP-Mod and show how to implement them in R. Neal Thomas (Pfizer) will present further technical details of MCP-Mod by evaluating the method using results from least squares linear model theory. Please visit PSI website for more details.
May 08 2019 |
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Apr
12
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Workshop on Estimands
The workshop introduces participants to Estimands, its background, components and how to build statistical analysis models under the framework. The presentation content would be on background of Estimands with examples followed by components of Estimands and its uses in the study reporting including the statistical methods. Participants will be grouped, and each group will receive copies of the clinical objectives and the components of Estimands. Groups are expected to build Estimands based on the clinical question given with statistical methodologies implementation and present the same with wider audience. The workshop intends to cover background and components of Estimands , Analysis methods for the missing data with case studies and hands-on exercises. Intended audience: Statisticians who are writing/reviewing/approving Protocol/Statistical Analysis Plan/ Reporting Analysis plans or person works in clinical industry who support the statistical analysis.
Apr 12 2019 | The Capitol Hotel, No - 3, Raj Bhavan Road, Vasanth Nagar, Bengaluru, Karnataka 560001
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