24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
09:30 – Welcome Address & Opening Remarks
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
REGULATORY
09:40 – KEYNOTE PANEL SESSION: Stay Ahead of Regulatory Changes - Insights
- Packaging & labelling - How the pharma industry is keeping up with changing regulations and compliance
- Updates - Latest regulations in Packaging and Labelling, Track & Trace
- Streamlining compliance processes with best possible regulatory practices
- The near future such as Drug Supply Chain Security Act (DSCSA).
- Weighing the advantages and regulatory guidelines for digital and e-labelling vs paper labels
- Gearing yourself up for upcoming regulations to stay competitive and relevant
- Where are we heading and what’s the way forward?
CHAKRAVARTHI AVPS, Global Ambassador, World Packaging Organisation
Panellists:
SATYA BABU, Sr. VP and Head - Operations, Quality, Regulatory and Scientific Affairs, Biological E
LOGANATHAN S, AVP – Device & Packaging Development, Stelis Biopharma
RAM BALANI, CEO / Founder, eSTARHelper (USA)
LOKESH PATEL, Founder Director, URL Aseptic Automation
SRIDHAR REDDY BADDURI, AVP Operations, Annora Pharma
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
REGULATORY COMPLIANCE
10:40 – “Boosting DSCSA Regulatory Preparedness for FDA’s Drug Supply Chain Security Act Compliance with Copilot Integrated Generative AI / ML”
- Define what FDA DSCSA is and why it was created by US Congress, one-year preparedness extension and mandatory November 2024 regulatory compliance.
- Challenges for regulatory compliance with DSCSA to meet drug supply chain security mandates-some mandates apply to all drug industry stakeholders while others regulation do not depending on trading partner roles & exemptions- learning Who’s doing what & when can be daunting for FDA compliance
- Discussing why many remain unprepared highlighting the search gauntlet with US FDA.Gov website hosted regulatory contents (Guidance & 21 CFRs) relying on abysmal metadata searching specific on one hand and Google browser search web noise or clutter on the other when seeking DSCSA relevant context specific information
- Introducing with illustrations the new AI/ML underpinned Microsoft Copilot & chatbot platform/ technology with underlying AI/ML generative technology via ChatpGPT-4 LLM (Large Language Model) under the hood- featuring unique benefits (RAG-Retrieval Augmented Generation) and revealing caveats with AI/ML inherent bias with data source har vested citations.
- Extending Copilot with your custom enterprise external data and leveraging cloud-based Microsoft Sharepoint Online Full-Text search on actual US FDA collections hosted within Sharepoint to fact check or verify generative response accuracy by you-the-human
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
11:20 – Morning Tea / Coffee & Networking
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
11:50 – Serialization: Current Trends, Upcoming Compliances and Opportunities LOKESH PATEL, Founder Director, URL Aseptic Automation
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
12:30 – Non Clonable Serialization
- Packaging Security In Supply chain Remains Unsolved and Continues To Be A Topic Of Discussion - Industry Remains Dis-appointed And Keeps Experimenting With Known Paradigm of Multi-layer Overt/Covert Security Features And That Becomes More of Posturing.
- Due to The Technology Gap Hidden Cost On Legal & Orchestrated Ground Investigations Are Rising . Security Features Offered From Different Part Of World Is Primitive - These Adversely Impacts Consumer Participation. Vendors Are Not Capable Of Underwriting Performance Liability. IS There Any Better Way Out ??
- Achieving Non Clonable Printing In Standard Print-lines That Transforms Existing Regulatory Serialization To Non Clonable Serialization. Learn With Example of 6 Billions Non Clonable Print-impressions Deployed - How It Can Render Security, Sustainability & Costeffectiveness Together With Performance Liability And Minimization Of Ground Investigation
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
13:00 – Networking luncheon
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
CHALLENGES & OPPORTUNITIES
14:00 – DISCUSSION WITH EXPERTS: Packaging & Labelling: Playing with innovations & latest developments in Serialization, Track & Trace – Fight against the FAKES
- Pharma Packaging Counterfeiting: A Global Threat.
- Labelling & Quality: Optimizing global labelling operations & packaging quality control.
- Serialization, Track & Trace are great but aren’t we lacking global standards and transparency?
- Assessing feedback from customers when working on designs and packaging
- Reviewing new packaging materials to create business continuity and reduce cost
- How can serialization, track and trace and other technologies be used to improve the safety of patients and drug efficacy?
- Developing strategies for current and future UDI (Unique Device Identifier) processes and procedures to manage global requirements
- Improve efficiencies in artwork & labeling to implementation
- Developing and sustaining brilliant packaging labeling and artwork capabilities
Moderator
PRASAD SATAM, Vice President & Head - Packaging Research Development, Aurobindo Pharma
Panellists
LOKESH PATEL, Founder Director, URL Aseptic Automation
RAMAKRISHNA BOLISETI, AVP Operations, Hetero Labs
PRASHANT KUMAR GUPTA, Vice President & Chief Business Officer, Shriram Veritech Solutions
BALARAM PATRO, CEO, GRK Research Laboratories
SEKHAR BABU PULI, Head - Packaging Development, MSN Laboratories
UTTAM CHAKRAVARTY, Lead Packaging Development, Sandoz
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
15:00 – Driving innovation in pharma, biopharma - Opportunities and Challenges
LOGANATHAN S, AVP – Device & Packaging Development, Stelis Biopharma
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
15:30 – Afternoon Tea / Coffee
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
SUPPLY CHAIN
16:00 – DISCUSSION WITH EXPERTS: Enhancing your Supply Chain - Building resilient supply chains in the evolving pharma environment
- Attaining alternatives in SCM to mitigate disruptions to production timelines
- How can serialization, track and trace and other supply chain technology be integrated to create visibility and transparency from end-to-end?
- What are your plans for the digital transformation of your supply chain
- How to avoid counterfeits and make your supply chain and products more secure?
- How pharmaceutical companies should develop a reliable and sustainable supply chain?
- Key obstacles / Overcoming challenges / Enhancing efficiency
Moderator
AVINASH KUMAR TALWAR, VP - MRO & Pkg. Material Sourcing (Strategic & Plant), Global SCM, Dr. Reddy’s Laboratories
Panellists
P.V. RAJU, Senior VP Supply Chain, Biological E
KAMARAJ ABRAHAM, Associate VP, Head Quality Assurance, Aurobindo Pharma
MANJEETH SINGH RAWAT, Head Supply Chain - China, CIS & Romania, Dr. Reddy’s Laboratories
SURYANARAYANA REDDY, Senior VP & Head Quality Assurance, NATCO Pharma
ASHISH ANAND, Technical Director, Linksmart Technologies
24th July 6th Annual Pharma Packaging, Labelling, Serialisation, Track & Trace, Supply Chain 2024
17:00 – Closing remarks and end of conference