Agenda
08:30 | REGISTRATION & NETWORKING
09:00 | Welcome Address by
Pradeep Sippy, Project Director, Bluetech Media
09.10 – 09.30 | Keynote Address
Dr. Ashok Kumar Bhattacharya, PhD (HC) Former Executive Director, Takeda
09:30 – 10:15 | PANEL DISCUSSION:
API Industry – Current Global Trends & Status of Indian API Industry.
- How India can compete with China in API Industry
- Enhancing efficiency in production processes
- Rapid Drug Discovery & Development
- Growing FDI inflows
Moderator
- Dr Ashok Kumar Bhattacharya, PhD (HC) Former Executive Director, Takeda Pharmaceuticals India Pvt. Ltd.
Panellist
- Dr Pradnya Deshmukh, Former President Quality, Wockhardt
- Dr Roshan Palewar, CEO, DocRoSh Global Solutions
- Omprakash shobhraj Sadhwani, Former Joint Commissioner FDA, Maharashtra
- Pradeep Sharma, Head Supply Chain, Sun Pharma
- Rajni Jha, IIT Kanpur Scholar, Synthetic Organic Chemistry, Trainer for QBD, GM& Regulatory Affairs
10:20 – 10:50 | Presentation
Identification of Nitrosamines in Drug Substance and Risk Based Approach for its Evaluation
- Dr Arijit Das, VP & Global API R&D Head, Cipla
11:00 | NETWORKING COFFEE BREAK
11:20 – 12:00 | Panel Discussion
FDA Inspectional concerns regarding API manufacturing facilities in India Categories, Causes, Challenges & Circumvention
Moderator Rajni Jha, IIT Kanpur Scholar, Synthetic Organic Chemistry, Trainer for QBD, GM& Regulatory Affairs
Panelist
- Sarang Bhunje, Vice President Head Quality API Operations, Cipla
- Dharmesh Karwar, Director, NGB Laboratories
- Dr Rajendra Chavda, VP R&D API, BDR LiveScience
12:05 – 12:30 | Presentation
Digitalizing Tech Transfer for API Industry
- Krishna A, Industry Consultant Life Sciences, Rockwell Automation
12:35 – 13:10 | Presentation
API – lifecycle and cost saving measures
- Pradnya Deshmukh, Senior Quality Professional, Former President Quality Wockhardt Ltd
13:10 – 14.05 | CONFERENCE LUNCH
14.10 – 14.40 | Presentation
Impurities in Drug Substances / Products – Current Global Guidance
- Dr Andiaapan Murugan, VP R&D API, Troikaa Pharmaceuticals Ltd
14.40 – 15.10 | Presentation
Track & Trace in Pharma API
- Rajan Sundavadra, Product Architect, Jekson Vision
15.10 – 15.40 | Presentation
GMP Inspection Relevance for API Manufacturing
- Manoj Chitnis, VP Corporate Quality, JB Pharma
15:40 – 16:10 | Speed Geeking Session & Networking Break
16:10 – 16:35 | Presentation
Critical Success Factors for successful launch and continuation of API: How Pharmacovigilance contributes
- Dr. Shraddha Bhange MD Medical Director Safety Science Pharmacovigilance, Compliance Business Unit
16:40 – 17:05 | Presentation
Newer Expectations related to microbial/dissolution profile control of API’s.
- Vijay Kshirsagar, Director, TRAC Pharma Consulting
17.05 | Closing Remark of Day 1
08:30 REGISTRATION & NETWORKING
09:00 Welcome Address by
Ashish Chauhan, Director, Bluetech Media
09:05 – 09:45 PANEL DISCUSSION
Efficient Development, Scale up, & Tech transfer of API up to Commercial scale
- Incorporation of Quality by Design & Risk Evaluation Management Strategy at Development Stage
- Adopting Continuous Manufacturing in improving product quality
- Overcoming challenging logistics of high containment requirements.
- Timely Entry into Relevant Markets
- cGMP Compliance & Optimalization of Manufacturing Process
Moderator:
- Rajni Jha, IIT Kanpur Scholar Pharmaceutical Consultant, Synthetic Organic Chemistry, Trainer for Qbd, GMP, and Regulatory Affairs
Panelists:
- Dr Rakesh Ganorkar, Vice President, R&D Hikal
- Dr Venkatesh Katgeri, Vice President, Srikem Laboratories
- Dr Abhijit Roychowdhary, Director, Emcure Pharmaceuticals Ltd
- Paramvir Bhadwal, Head API R&D, Farmson Pharmaceuticals
09:45 – 10.15 Presentation
Addressing Scale up concerns right from the R&D to Commercial Scale
- Dr Narender Rao, Somisetti VP Head – R&D, Metrochem API
10:15 – 10.45 Presentation
The Philosophy for Sustainable Growth in Generic API World
- Dr Ashok Kumar, President, IPCA Laboratories
10:45 – 11.05 NETWORKING COFFEE BREAK
11:05 – 11:45 Panel Discussion
Reshaping the Pharmaceutical Industry with Digital Transformation
- Enhanced Data Security starting from Drug Discovery to Mobile Centric Trials – Innovations
- Drug Discovery through AI
- Predictive Analysis
- Enhanced Security with Block Chain
Moderator:
- Ashok Bhattacharya, Former Executive Director, Takeda Pharmaceuticals
Panelists:
- Ankit Jain, Industry Consultant (Asia Pacific) Life Sciences Rockwell Automation
- Deepa Pangaonkar, Global Head Quality IT Wockhardt Ltd
- Kumaresan M, Unichem Laboratories CIO / Head of Information Technology
11:45 – 12:15 Presentation
Particle Size of API on Formulation Success
- Paramvir Bhadwal, Head (API R&D), Farmson Pharmaceuticals
12:15 – 12:45 Presentation
Regulatory Updates & Challenges for API Industry Information sharing between API manufacture & Drug Product Manufacturer
- Dr Venkatesh Katgeri, Vice- President, Srikem, Laboratories
13:00 – 14:00 CONFERENCE LUNCH
14:00 – 14:30 Presentation
Continuous Crystallisation of Active Pharmaceutical Ingredients
- Dr Rajendra Chavda, VP R&D API, BDR LiveScience
14:30 – 15:00 Presentation
Development, scale up & Technology Transfer of APIs post the Covid-19 debacle- Complexity, Challenges & Circumvention
- Rajni Jha IIT Kanpur Scholar Pharmaceutical Consultant, Synthetic Organic Chemistry, Trainer for Qbd, GMP, and Regulatory Affairs
15.05 – 15.35 Presentation
Future of API Business in India
- K Anand CEO & Managing Director Qualiminds
15.35 Lucky Draw
15.45 Closing Remarks