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“Perfect blend of the topics based in biosimilars. All the speakers were well educated and experienced on the respective topics”

Anita Ghagare , Senior Manager, Unichem Laboratories


“The conference was useful in providing knowledge on regulatory guidelines and process development”

Mannan Khambati , Senior Manager, Bharat Serums and Vaccines

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Organised By
  
 
 
     
     
PRE-CLINICAL AND CLINICAL TRIALS WORKSHOP – THURSDAY 29 MARCH 2012
   
Registration: 09:30
   
Workshop: 10:00-16:00
   
Lunch: 13:00-14:00
 
There will be two refreshment breaks during the day
   
AGENDA :
   
1. Determining the latest pre-clinical and clinical regulatory requirements, both domestic and international, to fast track the approval and registration process of biosimilars and increase export opportunities. The complexities of regulations and guidelines for biosimilars in India, US, Europe, as well as emerging markets such as South America, South East Asia, Russia, Middle East and Africa, will be discussed.
 
  • Understanding the latest pre-clinical and clinical regulations to ensure compliance with the regulatory requirements of the country
  • Determining the steps and procedures required to fast track the approval process of your pre-clinical and clinical trials
  • Establishing the documentation and procedures required to conduct successful trials
  • Clarifying the types of trials to be performed for the development of biosimilars and its variances from country to country
  • Evaluating in-vitro and in-vivo studies to be performed for successful completion of pre-clinical and clinical studies
   
2. Designing and identifying the key steps and robust processes in pre-clinical and clinical trials to successfully conduct a commercially viable trial
 
  • Key requirements
  • Precautions
   
3. Challenges in toxicological evaluation of similar biologics
 
  • Designing pre-clinical studies to do effective comparative evaluation of similar biologic with innovator product
  • Evaluating the type of animal model selected to carry out toxicity testing for pharmacological responsive strain
  • Understanding the usage of transgenic animal models in case of non-availability of relevant animal models
  • Determining the dose administration to mimic therapeutic schedules
  • Examining the minimum recommended dose levels of 1X, 2X and 5X with reference product to be tested at 1X
  • Assessing the requirements for pre-clinical studies to be conducted at Good Laboratory Practices (GLP) facilities
  S Harinarayana Rao,
Research Director, Laboratory Animal Research Services,
Reliance Life Sciences
   
WORKSHOP RATIONALE:
   
  Due to the inherent complexity of biologics, the manufacturing and characterisation processes should be thoroughly designed to ensure a product’s quality, safety and efficacy. This can be only achieved by proper pre-clinical and clinical studies. This unique practical workshop will equip you with all necessary guidelines which will help you to conduct a successful commercially viable trial.
   
BENEFITS OF ATTENDING:
   
  This essential learning forum will provide you with a detailed overview of pre-clinical and clinical trials and will share real-life implementable examples of companies where effective trials have recently played a major role in the successful development of biosimilars. In this workshop, our expert trainers will update you with the latest regulatory requirements to fast track the approval process of your biosimilars. It will also cover key steps to be undertaken to conduct a cost-effective trial and will give you insights on Good Laboratory Practices (GLP).
   
 
 
 
 
 
 
 
 
     
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