Previous Events

  1. One-Day Workshop on "Concepts of Bioequivalence from Statistical Point of View" for non-statisticians, Ahmedabad, March 2014

    First time in Gujarat, one day workshop has been organized for non-statisticians exclusively on bio-equivalence statistics, with large number of participants. More than 13-pharmaceuticals & CROs had participated in this workshop from across India.

     
    Conducted by: PHARMA-STATS
     
    Date: 9th March 2014, Sunday
    Time: 9:00 am to 5:00 pm

    Venue: Platinum Inn, Near Anjali cross roads, Vasana, Ahmedabad (India)

    This workshop specially designed for non-statisticians working in bioequivalence domain:

    • responsible for bioequivalence study planning & designing
    • protocol-report writing, quality assurance, regulatory clinical-queries & audits
    • outsourcing bioequivalence projects
    • involved in review and discussion of pilot/failed study
    • and would like to understand all statistical concepts behind above responsibilities.

    However, you may still be wondering "Why do I need to attend this workshop?" or "What future benefit can I get from a statistics class?"

     Clear concepts of bioequivalence statistics will help:

    • in effective planning & design of the study
    • to read, evaluate & discuss study outcomes
    • to further develop critical thinking and analytic skills
    • to know when you need to hire outside statistical help
    • to understand importance of ‘cleaned’ data in bioequivalence

    Here, instead of ‘teaching statistics’; we are delivering ‘concepts behind statistics’.

    Whether you are experienced or relatively new in the profession, this is an excellent opportunity to upgrade your biostatistical skills! Please inform to your friends/colleagues whoever is interested or working in such area. 

     
     
     

     

  2. Understanding the outcome of BE studies with Biostatistical concepts, Mumbai, January 2014

    Workshop: Conducted by Pharma Edge Center (I) Pvt. Ltd. at Mumbai on 25-26th January, 2014

    Title: “Use of Biowaivers as in-vivo surrogate, basic concepts of in vitro-in vivo correlation (ivivc) & Understanding statistical outcome of BE studies through examples for non-statisticians."

    Speakers:

    1. Nirali Mehta (PHARMA-STATS)
    2. Dr. J.M.Cardot (Faculte de Pharmacie Laboratoire de Biopharmacie, France)
    3. Dr. Vinay Shedbalkar (Pharma Edge)
  3. One day workshop on Biostatistics, Bioequivalence & regulatory issues at Dr. Reddy's, Hyderabad, April 2015

     Workshop: One day workshop on Biostatistics, Bioequivalence & regulatory issues at Hyderabad, April 2015

     

    Conducted By: Dr. Reddy's

     Date: 28th April 2015

     Venue: Hotel Avasa, Hyderabad, India

     Title: Fellowship in Clinical Research

     Topics:

     1. Basic Statistical Concepts (p-value, Hypothesis, ANOVA, Qualitative data vs. quantitative data, relationship between type-I/II errors and alpha/beta)

     2. Sample size justification & calculation

     3. Understand complete Bioequivalence analysis in 3-steps with case study (Read and interpret SAS output of BE analaysis)

     4. Statistical reasons behind failure of study

     5. Clinical Trials -adaprive design

     6. Regulatory issues on - Outlier, Linear log vs. Trapezoidal rule, Advance replicate designs

    Audiance: Key team members of Clinical, Regulatory affairs, medico marketing employees of Dr. Reddy's belongs to India, USA, EU, China, Russia, South africa, Ukraine and other countries

     

     

  4. Statistical considerations from clinical point of view at American Society of Clinical Oncology (ASCO), Hyderabad, March 2016

    Presenter & trainer at International Clinical Trials Workshop(ICTW) during 34th ICON

    Organized by: ASCO-American Society of Clinical Oncology

    Title: Statistical considerations from clinical point of view

    Date:12th March, 2016

    Venue: Hotel NOVOTEL, Hyderabad 

     

  5. 2-days workshop on “Concepts of Bioequivalence from statistical point of view” for non-statisticians organized by Cadila Healthcare Ltd., Ahmedabad, June 2016

    PHARMA-STATS had conducted 2-days workshop on “Concepts of Bioequivalence from statistical point of view” for non-statisticians

    Organized by: Cadila Healthcare Ltd.(Zydus Cadila)

    Venue: Hotel Aloft, Ahmedabad

    Date: 20th-21st June, 2016

     

  6. 2-days workshop on “Statistical Concepts in Bioequivalence Studies” organized by Alembic Pharmaceuticals Ltd., at Alembic Research Center, Vadodara, September 2016

    PHARMA-STATS had Conducted 2-days workshop on “Statistical Concepts in Bioequivalence Studies”

    Organized by: Alembic Pharmaceuticals Ltd.

    Venue: Alembic Research Centre, Vadodara

    Date: 9th-10th September, 2016

  7. 6-days workshop on “CDISC Standards: Implementation, Regulatory Requirements and Application in Bioequivalence Studies”, organized for Sun Pharmaceutical Industries Ltd. , Ahmedabad, March 2017

    PHARMA-STATS had conducted 6-days workshop on “CDISC Standards: Implementation, Regulatory Requirements and Application in Bioequivalence Studies”

    Organized by: Sun Pharmaceutical Industries Ltd. (Vadodara)

    Location: PHARMA-STATS, Ahmedabad

    Date: February-March 2017 (Weekend base)