Regulatory Requirements for Biopharmaceuticals From Science to Commercialization. Day I: 30 July 2013

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1 9.00 am to 9.30 am: Registration and Tea 9.30 am to 9.45 am: Inaugural Session Day I: 30 July :45 am to am: Theme Address by Dr. V P Kamboj, Former Director CDRI am to am: Session I: Best practices in Biological Discovery and Development Process Session Moderator: Kanury Rao, ICGEB (15 Minutes) Lead Speaker: Venkata Ramana, Reliance Life Sciences (45 Minutes) Introduction to Discovery and Development of Biopharmaceuticals Lead identification, Lead optimization and Validation Feasibility and Safety issues related to candidate selection Case study highlighting the requirements of regulatory guidance documents Highlighting the issues related to Discovery and Development process Finding the probable feasible solutions 11.45am to noon: NETWORKING TEA noon to 1.30 pm: Session II: Best Practices in Product Expression Session Moderator: Sajeev Gupta, Intas Biopharmaceuticals Ltd (15 Minutes) Lead Speaker: A K Panda, National Institute of Immunology (45 Minutes) Understanding the Cloning, Vector development and high yield Cell Line selection that will aid the development of biologics Maximising fermentation and cell line capacity by building robust scale up strategies in Upstream process

2 Highlighting the issues related to Product Expression process 1.30 pm to 2.30 pm: LUNCH 2.30 pm to 4.00 pm: Session III: Best Practices in Scale Up and Manufacturing Process Moderator: Sanjay Singh, Gennova Biopharmaceuticals Pvt Ltd. (15 Minutes) Lead Speaker: Anurag Rathore, IIT New Delhi (45 Minutes) Navigating roadblocks around Upstream and Downstream process to improve product quality Evaluating the latest techniques and overcoming complexities to develop a high standard quality of biologics Robust approaches and scale up strategies in the Biopharmaceutical manufacturing process Highlighting the issues related to Scale up and Manufacturing Process 4.00 pm to 4.15 pm: NETWORKING TEA 4.15 pm to 5.45 pm: Session IV: Best Practices in Product Characterisation and Comparability Exercise Moderator: Shivraj Dasari, SLS Cell Cure Technologies (15 Minutes) Lead Speaker: Sriram Akundi, Biocon (45 Minutes)

3 Product comparability exercise with the innovator product at all levels of product development: Level 1: Physiochemical comparability Level 2: Comparability in biological characteristics Level 3: Confirming similarity in preclinical stage Level 4: Comparability exercise in Phase I clinical trials Level 5: Comparability exercise in Phase III clinical trials Understanding Characterisation requirements for effective development of Biopharmaceuticals Understanding the state of the art analytical methods that will enhance product comparability Categorization of multiple product variants into product related substances or impurities Highlighting the issues related to Product Characterisation and Comparability Exercise 5.45 pm to 6.00 pm: Summary and Wrap Up: Anurag Rathore, IIT New Delhi

4 Day II: 31 July 2013 Session I: Introduction to CDSCO and Regulations 9.30 am to am: Brief about CDSCO Biological Division Brief about CDSCO Highlighting the structure of various Biological divisions at CDSCO, Zonal, Sub zonal Offices, Central Laboratories Role of State Licensing Authorities Speaker: S P Shani, DDC(I), CDSCO am to am: Current Rules and Regulatory procedures for Biopharmaceuticals am to 11.15: NETWORKING TEA Regulatory procedures applicable to clinical trials and marketing authorizations Agencies involved (DBT, RCGM, GEAC, IBSC) Speakers: A.B. Ramteke, CDSA and Rajat Goyal, IAVI am to pm: Session II: Pre Clinical / Animal Experiments Moderator: Vyas Madhavrao Shingatgeri, Ranbaxy (15 Minutes) Lead Speaker: Harinarayan Rao, Reliance Life Sciences (45 Minutes) Pre clinical data requirement for RCGM in case of r DNA Products Determining best practice strategies to overcome issues and Challenges in animal trials Learning innovative and modern methods for Pre Clinical testing to avoid unnecessary delays, and ensure swift product approval Specific Documentation requirements for pre clinical trials to meet international standards Highlighting the issues related to Pre Clinical Trials

5 12.45 pm to 1.45 pm: LUNCH 1.45 pm to 3.15 pm: Session III: The Clinical Development of Biopharmaceuticals Moderator: Rajat Goyal, IAVI (15 Minutes) Lead Speaker: Arani Chatterjee, Panacea Biotec Ltd (45 Minutes) Understanding the latest clinical trials regulatory guidelines as per DCGI/NDAC and ICMR Understanding the role of Ethics committee Clinical requirements to demonstrate Safety, Efficacy and immunogenicity parameters of Biopharmaceuticals Clinical trial documentation standards for Biopharmaceuticals The Pharmacovigilance requirements Highlighting the issues related to Clinical Trials 3.15 pm to 3.30 pm: NETWORKING TEA 3.30 pm to 4.30pm: Session IV: Comparison with Global Biopharmaceuticals Standards Latest updates on biopharmaceuticals regulatory landscape in US and Europe Lead Speaker: Anurag Rathore, IIT New Delhi 4.30 pm to 5.00 pm: Session V: Sharing the Industry challenges and Case studies Moderator: Rajat Goyal, IAVI Approval and Technical Challenges faced by the Biopharmaceutical companies Case studies by Representative from participant Industries 5.00 pm to 5.30 pm: Concluding Session and Closure of the Workshop