Workshop on Review Procedure Adopted for Evaluation of New Drug Application, BA/ BE Study and Marketing Permission from 24 th 27 th February, 2014 at
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1 Workshop on Review Procedure Adopted for Evaluation of New Drug Application, BA/ BE Study and Marketing Permission from 24 th 27 th February, 2014 at New Delhi
2 Objective of the Workshop The primary objective of the workshop was to improve the understanding and reviewing capacity of BA/ BE data submitted as a part of new drug application and to train the Drugs Inspectors on inspections of BA/ BE study.
3 Agenda of the Workshop 24 February 2014 (Day 1): S.No. Topic Time (Hr.) Faculty/Facilitator 1 Registration 09:30 10:00 CDSCO 2 Theme / Key note address 10:00 10:30 CDSCO 3 Refreshments 10:30 10: Introduction to BA / BE study 10:50 11:20 5 Study Specific Procedures & Clinical Pharmacology Unit 11:20 13:00 6 Lunch 13:00 13: Study related Documents 13:45 15:30 8 Refreshments 15:30 15:50 -- Dr. Vishwas D Sangle Glenmark Generics Ltd., Dr. Gauri Patel Cliantha Research Limited Dr. Munish Kaushik Jubilant Life Sciences Limited 9 Study Report 15:50 16:30 Dr. Munish Kaushik 10 Group Exercise & Case Studies 16:30 17:00 Jubilant Life Sciences Limited 11 Open House discussion 17:00 17:30 Participants
4 25 February 2014 (Day 2): S.No. Topic Time (Hr.) Faculty/Facilitator 1 Bio-analysis 09:30 10:30 Mr. Sandeep Sharma Jubilant Life Sciences Limited 2 Refreshments 10:30 10: Data Analysis Statistical Analysis 10:50 11:35 Mr.Rajneesh Singh Fortis Clinical Research Ltd 4 Group Exercise & Case Studies 11:35 12: Open House Discussion 12:30 13: Lunch 13:00 13:45 --
5 26 February 2014 (Day 1): S.No. Topic Time (Hr.) Faculty / Facilitator 1 Registration 09:30 10:00 CDSCO 2 Introduction 10:00 10:15 CDSCO 3 Pre Workshop Assessment 10:15 10: Tea / Coffee Break 10:30 10: Introduction to BA / BE study 10:50 11:20 6 Study Specific Procedures & Clinical Pharmacology Unit 11:20 13:00 Dr. Vishwas D Sangle Glenmark Generics Ltd., Dr. Gauri Patel Cliantha Research Limited 7 Lunch 13:00 13: Study related Documents 13:45 15:30 Dr. Munish Kaushik Jubilant Life Sciences Limited 9 Tea / Coffee Break 15:30 15: Study Report 15:50 16:30 11 Group Exercise & Case Studies 16:30 17:00 Dr. Munish Kaushik Jubilant Life Sciences Limited 12 Open House discussion 17:00 17:30 Participants
6 27 February 2014 (Day 2): S.No. Topic Time (Hr.) Faculty / Facilitator 1 Bioanalysis 09:30 10:30 Mr. Sandeep Sharma Jubilant Life Sciences Limited 2 Tea / Coffee Break 10:30 10: Data Analysis Statistical Analysis 10:50 11:35 Mr.Rajneesh Singh Fortis Clinical Research Ltd 4 Group Exercise & Case Studies 11:35 12: Post Workshop Assessment 12:30 13: Lunch 13:00 13: Regulatory & Industrial Challenges in Bioanalytical & Monitoring Investigations of the Bioanalytical failures Phase I studies Vs BA/BE Studies 13:45 14:30 Dr. Rachna Arora Ranbaxy Laboratories Limited
7 List of Participants: 24 th 25 th February: S.No. Facilitators Designation Organization Resource Persons/Facilitators 1 Deputy Drugs Controller CDSCO, HQ Dr. A. Ramkishan (India) 2 Assistant Drugs Controller CDSCO, HQ Ms. Rubina Bose (India) 3 Dr. Vishwas D Sangle Deputy General Manager Glenmarks Generics Ltd. 4 Dr. Gauri Patel - Cliantha Research Ltd. 5 Dr. Munish Kumar Kaushik Associate Director-PV Jubilant Clincys Ltd. 6 Mr. Sandeep Sharma Director-BA/BE Jubilant Life science Ltd. 7 Senior Biostatistician Fortis Clinical Research Mr. Rajneesh Singh Ltd. Participants 8 Mr. Amol Eknath Kandekar Drugs Inspector CDSCO, HQ 9 Mr. Manish Singhal Drugs Inspector CDSCO, HQ 10 Mr. P. Manavalan Drugs Inspector CDSCO, Chandigarh 11 Mr. Deshraj Singh Drugs Inspector CDSCO, WZ 12 Ms. Sarala Devi Drugs Inspector CDSCO, Hyderabad 13 Mr. Deepak Kumar Drugs Inspector CDSCO, WZ 14 Mr. Suresh Kumar Kalwaniya Drugs Inspector CDSCO, HQ 15 Ms. Nisha Kaushik Drugs Inspector CDSCO, HQ
8 16 Mr. Saurabh Garg Drugs Inspector CDSCO, HQ 17 Ms. Sudarmathi S Drugs Inspector CDSCO, HQ 18 Mr. Popat Dattatraya Thorat Drugs Inspector CDSCO, HQ 19 Dr. Kasi Sankar Drugs Inspector CDSCO, HQ 20 Mr. Devendra Nath Drugs Inspector CDSCO, HQ 21 Mr. Rahul Panwar Drugs Inspector CDSCO, HQ 22 Ms. Sunitha Seerapu Drugs Inspector CDSCO, HQ 23 Mr. Bidya Sekhar Mishra Drugs Inspector CDSCO, HQ 24 Mr. V Sooraj Drugs Inspector CDSCO, HQ 25 Mr. Basant Kumar Yadav Drugs Inspector CDSCO, HQ 26 Dr. Vijai Singh Karwasara Drugs Inspector CDSCO, HQ 27 Mr. Pushpraj Kumar Singh Drugs Inspector CDSCO, HQ 28 Mr. Avinash Kumar Yadav Drugs Inspector CDSCO, HQ 29 Mr. Dileep Kumar Drugs Inspector CDSCO, HQ 30 Mr. Shabeer Ashfaque Abdulla Drugs Inspector CDSCO, HQ 31 Mr. Rahul Singh Drugs Inspector CDSCO, HQ 32 Mr. Pratyush Kumar Drugs Inspector CDSCO, HQ 33 Mr. Bikramaditya Chowdhury Drugs Inspector CDSCO, HQ 34 Mr. Bibekananda Behera Drugs Inspector CDSCO, HQ 35 Mr. Jay Jyoti Roy Drugs Inspector CDSCO, HQ 36 Ms. Kiran Singh Drugs Inspector CDSCO, HQ 37 Dr. Bikash Roy Drugs Inspector CDSCO, HQ 38 Mr. Navneet Pratap Singh Drugs Inspector CDSCO, Goa 39 Mr. Ashok GM Cliantha Research Ltd Dr. Ashwini Sawant Research officer Glenmarks Generics Ltd41 41 Mr. Anshuman Rai Executive Glenmarks Generics Ltd. 42 Mr. Kuldeep Namdev Pharmacokinetic Scientist Fortis Clinical Research Ltd.
9 26 th 27 th February: S.No. Facilitators Designation CDSCO Office Resource Persons/Facilitators 1 Dr. A. Ramkishan Deputy Drugs Controller (India) CDSCO, HQ 2 Ms. Rubina Bose Assistant Drugs Controller (India) CDSCO, HQ 3 Dr. Vishwas D Sangle Deputy General Manager Glenmarks Generics Ltd. 4 Dr. Gauri Patel - Cliantha Research Ltd. 5 Dr. Munish Kumar Kaushik Associate Director-PV Jubilant Clincys Ltd. 6 Mr. Sandeep Sharma Director-BA/BE Jubilant Life science Ltd. 7 Mr. Rajneesh Singh Senior Biostatistician Fortis Clinical Research Ltd. Participants 8 Mr. Saurabh Garg Drugs Inspector CDSCO, HQ 9 Mr. Devendra Nath Drugs Inspector CDSCO, HQ 10 Mr. Ashok Kumar Drugs Inspector CDSCO, WZ 11 Ms. Nisha Sankhwar Drugs Inspector CDSCO, HQ 12 Mr. Ashok Kumar Yadav Drugs Inspector CDSCO, Ahmedabad 13 Mr. Virendra Singh Drugs Inspector CDSCO, Ahmedabad 14 Mr. Rajaram Dharamraj Drugs Inspector CDSCO, HQ 15 Mr. Dharmvir Singh Drugs Inspector CDSCO, HQ 16 Mr. C. Arunachalam Drugs Inspector CDSCO, HQ 17 Mr. Ankur Bansal Drugs Inspector CDSCO, HQ 18 Mr. Dinesh Kumar Drugs Inspector CDSCO, HQ 19 Mr. Sourabh Mittal Drugs Inspector CDSCO, HQ 20 Mr. Sunil Kumar Malviya Drugs Inspector CDSCO, HQ 21 Mr. Abhinav Kapoor Drugs Inspector CDSCO, HQ 22 Mr. Deepak Kumar Sehrawat Drugs Inspector CDSCO, HQ 23 Mr. Akash Rama Kondalkar Drugs Inspector CDSCO, HQ 24 Ms. A Anbuselvi Drugs Inspector CDSCO, HQ 25 Mr. J.Sureshkumar Drugs Inspector CDSCO, HQ
10 26 Mr. Saurabh Jain Drugs Inspector CDSCO, HQ 27 Ms. C. Thiruvidha Drugs Inspector CDSCO, HQ 28 Mr. Rakesh Negi Drugs Inspector CDSCO, HQ 29 Mr. Parthiban J Drugs Inspector CDSCO, HQ 30 Mr. Arvind Singh Panwar Drugs Inspector CDSCO, HQ 31 Mr. Surender Kumar Kaswan Drugs Inspector CDSCO, HQ 32 Mr. Haribabu J Drugs Inspector CDSCO, HQ 33 Mr. Baljeet Sihag Drugs Inspector CDSCO, HQ 34 Ms. Suniti Choudhary Drugs Inspector CDSCO, HQ 35 Mr. Sachin Yadaorao Bhagwate Drugs Inspector CDSCO, HQ 36 Mr. Sri Babu Drugs Inspector CDSCO, HQ 37 Mr. Sandeep Kumar Drugs Inspector CDSCO, HQ 38 Mr. Manoj Choudhary Jatav Drugs Inspector CDSCO, HQ 39 Mr. Fahim Khan Drugs Inspector CDSCO, HQ 40 Mr. Mohan R. Drugs Inspector CDSCO, HQ 41 Mr. Manish Horo Drugs Inspector CDSCO, HQ 42 Mr. Balakumar Mahalingam Drugs Inspector CDSCO, HQ 43 Mr. Arun Kumar Prashar Drugs Inspector CDSCO, HQ 44 Mr. S. Gopinath Drugs Inspector CDSCO, NZ 45 Mr. Kailash Malik Drugs Inspector CDSCO, EZ 46 Mr. Anshuman Rai Executive Glenmarks Generics Ltd. 47 Mr. Kuldeep Namdev Pharmacokinetic Scientist Fortis Clinical Research Ltd.
11 Two days workshop on Review procedure adopted for Evaluation of New Drug Application, BA/ BE Study and Marketing Permission was carried out in two batches i.e. Batch-1 and Batch-2 from 24 th 25 th February 2014 and 26 th 27 th February 2014 respectively. Of the two days workshop, there were presentations by different representatives from the various BA/BE centers on both the days and there was a meeting between Stakeholders and CDSCO Officials on 25/02/2014 during post lunch session regarding various issues related to the BA/BE study in India.
12 There were presentations by different representatives from the BA/BE study centers. They discussed about need of BA / BE study, types of study, various components of BA/BE study protocol, study design, parameters to be evaluated, dose regimen, inclusion & exclusion criteria, statistical methods planned in the protocol and determination of sample size, efficacy evaluation, statistical analysis, introduction of ANDA & generics, practical approach to bioequivalence studies, regulatory requirement for BA/BE study reliable range of quantification, ULOQ, LLOQ, dilution, how well can the drug be measured in this range, Accuracy, precision, selectivity, how does sample handling affect the reliability of the measurement, Freeze-thaw, room temperature handling, injector stability, short, long term-stability, statistical analysis of data etc.
13 Ms. Rubina Bose, Assistant Drugs Controller (India), CDSCO welcomed all the experts and the participants and also gave brief introduction to the workshop.
14 Dr. A. Ramkishan, Deputy Drugs Controller (India), CDSCO addressing the participants about the importance of the workshop.
15 Presentations by different Speakers during Workshop
16 Participants during workshop (Batch-1)
17 Participants during workshop (Batch-2)
18 Participants during Pre-assessment and Post-assessment (Batch-1)
19 Participants during Pre-assessment and Post-assessment (Batch-2)
20 Participants during Pre-assessment and Post-assessment (Batch-2)
21 Dr. G.N. Singh, Drugs Controller General (India) addressing the Stakeholders on 25 February 2014
22 Dr. V.G. Somani, Joint Drugs Controller (India) addressing the Stakeholders Dr. A. Ramkishan, Deputy Drugs Controller (India) addressing the Stakeholders
23 Discussion of DCG(I) staff and various Stakeholders
24 Group Photograph during the Closing Ceremony of Workshop (Batch-1) Group Photograph during the Closing Ceremony of Workshop (Batch-2)
25 OUTCOME: Introduction to BA/BE studies such as definition, type, design of BA/BE study etc. BA/BE study protocol and its crucial components. Regulatory requirements of BA/BE studies. Role of statistical tool in evaluation of BA/BE data. Basic knowledge of Bioanalytical methods and method development. Knowledge of clinical sample analysis. Interpretation of the Clinical & Pharmacokinetics data, Statistical data and study protocol. Awareness on general requirement for the dossier submission to NRA. Knowledge on Guidance for Industry Requirements for permission of BA/BE Approval.
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