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