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Conference
PharmaLytica Conference 2023

The healthcare industry has raised the quality standards and is also moving swiftly towards digitalization.

PharmaLytica Conference 2023 will look at key topics like, Challenges and opportunities in moving towards digitalization, strategies for maintaining a global supply chain in a constrained environment and New analysis methods for the optimization of processes in the laboratory thereby transforming labs into smart technological labs.

The 2 day conference is an exclusive invite only event and will see key industry stalwarts discuss on strategies to charter the next phase of growth in pharma.

Clean Energy Partner
Conference Partner
Agenda
Agenda At A Glance:
Day 1

  1. CMO
  2. API
  3. Excipients
  4. Manufacturing
  5. Partnerships
  6. Development & Validation
  7. Lab & Analytical
  8. Telangana Life Sciences

Day 2

  1. Supply Chain
  2. OSD
  3. Digitalisation
  4. Quality & Risk Management
  5. RWE & RWD
  6. Packaging, Labelling, Serialization,Track & Trace
  7. Roadmap to 2024

Agenda
Agenda 2023
Time Topic
10:00 AM Welcome Address & Conference Inauguration
CONTRACT MANUFACTURING
11:00 AM
Keynote Panel Discussion –

Why the pharmaceutical industry is turning to outsourced manufacturing?

  • Collaborating with partners that meet your business needs
  • Points to be considered by pharma and bio-techs when choosing the right CMO
  • Assessing if your current partnerships are effective in achieving the desired output and standards
  • Understanding the needs, culture and relationship required to partner successfully with CMOs
  • Creating improvement opportunities with CMOs
  • Creating a win-win approach
  • Flexibility in operations and contractual agreements that don’t constrain development

Moderator:

  • VISHWAS SOVANI - Director, Pharma Wisdom

Panelists:

  • SUDEEP SRIVASTAVA, - Senior Vice President, Biological E. Limited
  • SATYA BABU - Sr. VP and Head - Operations, Quality, Regulatory and Scientific Affairs, Biological E. Limited
  • VIMAL KOTHAR - Associate Director - External Manufacturing, Dr. Reddy's Laboratories
  • ANISH AGARWAL - Global Head of Analytics, Dr. Reddy's Laboratories
  • PRAVEEN CHERUKUPALLI - Senior Vice President & Head-API R&D, Innovare Labs
SOLAR PV
12:00 PM
Presentation –

Solar PV Adoption for Pharmaceutical Industry for their operational cost savings and sustainability goals

  • Rooftop & Ground mount Solar PV solution suitability
  • OPEX, CAPEX & Open Access mode of Solar PV adoption
  • Case Study of Solar Adoption for a Pharmaceutical client

Speaker:

  • YOGISH HN - AVP–Business Development, Enerparc Energy
12:30 PM Lunch Break & Networking
API
13:30 PM
Panel Discussion –

Latest developments and trends in the Pharma API industry

  • How to reduce API manufacturing costs and get the best value for your money without cutting back on the importance of safety and containment procedures.
  • Importance of proper communication - Information sharing between the API manufacturer and the Drug Product manufacturer
  • Increasing trend toward more potent therapies and the consequences of the changing face of pharma
  • Comply - Must have QR code in each packing of API and medicine
  • Regulatory hurdles and opportunities

Moderator:

  • VISHWAS SOVANI - Director, Pharma Wisdom

Panelists:

  • NASIR ALI - Associate Vice President - API R&D, Aurobindo Pharma
  • KRISHNA BHAVANASI, - VP Head Formulation R&D, Natco Pharma
  • NARENDER RAO SOMISETTI - Vice President, Head-R & D, Metrochem API
  • SRINIVASA RAO - SAMBANGI, Sr. General Manager, Aurobindo Pharma
  • RAJNI JHA - IIT Kanpur Scholar Synthetic Organic Chemistry, Trainer for QBD, GMP n Regulatory Affairs & (Former Head Of Regulatory Affairs, Naari Pharma)
NITROSAMINE
14:30 PM
Presentation –

Nitrosamine Impurities in Pharmaceuticals

Speaker:

  • PRAVEEN CHERUKUPALLI - Senior Vice President & Head-API R&D, Innovare Labs
15:00 PM Coffee Break
ANALYTICAL PROCEDURES – DEVELOPMENT & VALIDATION
15:30 PM
Presentation –

Scientific approaches to analytical procedure development

  • Guidance to the analytical procedure development and validation of developed methods
  • Method performance through system suitability testing - future expectations from USP <621>
  • Practical challenges and suggested solutions
  • Key validation parameters that characterise analytical procedures
  • Use of analytical testing to support pharmaceutical quality systems
  • Discussion of analytical lifecycle management

Speaker:

  • BM RAO - CEO - QDOT Associates
LAB & ANALYTICAL
16:00 PM
Keynote Panel Discussion –

Pioneering laboratory knowledge - Future of Lab

  • Quality management in the laboratory
  • Sustainability in the laboratory / Lab automation / Lab and tech integration
  • Future-proofing labs through smart technology and innovation
  • Future of lab is digitalisation, automation and connectivity: Challenges & tools to engage staff
  • IoT in the Lab of medicinal Chemistry and the simultaneous impact of AI
  • Identify out-of-the-box systems and solutions
  • Review outdated processes, workflows, and tools
  • Safety and its journey towards improvement

Moderator:

  • PAWAN PATINGE - Founder, Academy of Analytical Instrumentation

Panelists:

  • SRINIVAS ACHANTA - VP, Dr. Reddy's Laboratories
  • GNANADEV GUDIPAT - Vice President ARD & QC Natco Pharma
  • BALARAM PATRO - CEO, GRK Research Laboratories
  • RAJESH THEMPADIYIL - Head – Quality Digital Transformation & Compliance, Dr. Reddy's Laboratories
17:00 PM End of Day 01
Time Topic
10:00 AM Welcome Address & Conference Inauguration
PHARMA SUPPLY CHAIN
11:00 AM
Keynote Panel Discussion –

Latest trends and developments in your supply chain – Moving up the value chain

  • Innovative strategies implemented from small-midsize pharma to overcome supply chain issues without incurring significant costs
  • Pragmatic solutions for overcoming supply chain hurdles
  • Transportation and logistics issues - where are we heading with this problem?
  • Common pitfalls in SCM - What are the lookout for facts?
  • How to insulate your risks against supply disruption
  • Steps needed to insure supply chain integrity from the raw material stage through the end user
  • Role of CFAs in in supply chain operation for effective drug supply / distribution to trade

Moderator:

  • VISHWAS SOVANI - Director, Pharma Wisdom

Panelists:

  • P V Raju - Senior Vice President Supply Chain, Biological E. Limited
  • KAMARAJ ABRAHAM - Associate Vice President, Head Quality Assurance, Aurobindo Pharma
  • APPAJI VENKAT - PADMANABHUNI, Policy Advisor, Pharmexcil
  • MANJEETH SINGH RAWAT - Head of Pharma Supply Chain - CIS & Romania, Dr. Reddy's Laboratories
  • HIMAL P. DESAI - Vice President, Supply Chain Management, Virchow Biotech
  • LAKSHMI NARAYANA - Associate Director, SCM, Aragen
OSD CONTRACT MANUFACTURING
12:00 AM
Presentation –

The Benefits of Expanding OSD Capacity

  • Niche manufacturing trends and techniques
  • Expectations when working with partners
  • Cost and price in manufacturing
  • Continued Development of Integrated Offerings
  • Safety aspects
  • Reality VS Expectations
12:30 PM Lunch Break & Networking
DIGITALISATION
13:30 PM
Panel Discussion –

Reshaping Pharma industry in the way of digital transformation

  • Looking Beyond Pharma 4.0: Future Initiatives and Advanced Manufacturing Approaches
  • What’s New? Innovation in Pharma Industry
  • Ensure the success of Technology Transfer
  • Addressing main challenges in implementing digitization in pharma
  • Making Big Data useful: Practical approaches
  • How is AI resolving the tech problems faced by the industry? How will the near future be?
  • Do digital trends really help in manufacturing? How?
  • Increasing Agility through Digitalization
  • Technological Evolution in Drug Manufacturing & Drug Delivery

Moderator:

  • RITHESH P - Director, Leading Technology Acceleration (Digital Solutions), Novartis

Panelists:

  • DILIP KASTALA - VP & Global Head - Digital, IT & Process Excellence, Dr. Reddy's Laboratories
  • RAM KUMAR - Director MSTG, Cipla
  • KAVITA LAMROR - Expert, Real World Investigator & RWD Product Owner, Sanofi
  • NARENDIRA KUMAR - Senior General Manger (Quality) | Site Quality Head, Viatris
QUALITY & RISK
14:30 PM
Presentation –

Quality culture excellence

  • To transform from "Compliance led" to "excellence led".
  • Guidance and tools for cultural assessment
  • Few QMS elements as Quality Culture enablers

Speaker:

  • NARENDIRA KUMAR - Senior General Manger (Quality) | Site Quality Head, Viatris
15:00 PM Coffee Break
RWD & RWE
15:30 PM
Presentation –

RWD & RWE - Creating value from next-generation real-world evidence

  • How Pharma will handle complexity of data in RWD?
  • Discussing how the RWE helps to get custom-made treatments and drug therapies for patients
  • What helps us to have a better understanding about data quality and data privacy?
  • RWE gives efficient and cost-effective clinical trials? How?
  • What are complications will rise by inserting new data source? And it leads to breakup in data?
  • Obtaining patient-centric using RWE
  • What kind of changes needed to be place in RWE?
  • Compelling with regulatory
  • Market access for innovative medicines in emerging markets

Speaker:

  • KAVITA LAMROR - Expert, Real World Investigator & RWD Product Owner, Sanofi
ROADMAP TO 2024
16:10 PM
Panel Discussion –

Future in Manufacturing – Roadmap to 2024 – Moving forward

  • Lessons learnt from Covid times – Making the best from the worst times.
  • Relationships with partners – How should this look by 2024
  • Over coming challenges – Increasing costs and competition
  • RWD and RWE drive in Pharma
  • Electronic Quality Management System- The Role of Modern software like Trackwise, EDMS, LIMS, LMS, e-BMR etc., in pharmaceutical industry and challenges facing during regulatory Audits.
  • USFDA focus on Recent Quality Management maturity program, Review of Quality metrics data and role of Electronic Quality Management System
  • Over coming regulatory constraints

Moderator:

  • SANDHYA PITTALA - Founder and COO, Crenza Pharmaceuticals

Panelists:

  • RAJENDAR BURKI - , Associate Vice President, (R&D), Biological E. Limited
  • K. SURESH BABU - Vice President- Quality Assurance, NATCO Pharma
  • RAHUL MITTAL - Head Strategy - Emerging Markets, Dr. Reddy's Laboratories
  • VIVEK JHA - Head - Strategy and Operations, Global Drug Development -India, Novartis
17:10 PM Break
PACKAGING, LABELLING, SERIALISATION, TRACK & TRACE
18:30 PM
Panel Discussion –

PPLST – Pharma Packaging Labelling Serialisation Track & Trace – Where are we heading? Which way is the right direction to improve?

  • Preparing for the future of pharma packaging
  • Fightback against counterfeit online medicine suppliers – How does the packaging help?
  • How packaging requirements for pharmaceuticals are changing in post pandemic?
  • Maintaining quality, traceability and accessibility in labeling.
  • Recent trends in serialization track and trace
  • New and major problems in implementing trace and trace in supply chain
  • Ensuring end to end supply chain in pharma – How the serialization helps maintaining dignity of products

Moderator -:

  • SANDHYA PITTALA - Founder and COO, Crenza Pharmaceuticals

Panelists:

  • GUNJAN SINGH - VP and Head Mature Markets API (US, EU, Mexico, Canada, CIS), Dr. Reddy's Laboratories
  • VINAY SINGH - Associate director – Supply Chain Management, Dr. Reddy's Laboratories
  • CHANDI PRASAD RAVIPATI, - Head - Packaging Development, Aurobindo Pharma
  • LOKESH PATEL - Founder Director, URL Aseptic Automation.
  • SUNIL CHANDUPATLA - AGM, Labelling, COE, Freyr Solutions
19:30 Networking Cocktail Dinner
Topics
Key Agenda Topics 2023

  • Latest developments and trends in the Pharma API industry
  • Pharma Machines & Manufacturing - Latest developments towards quality improvement
  • Method Validation to Optimisation and Automation in Analytical and Microbiological Laboratories
  • QR codes on API's, medicines and all drug packs - From Jan 01st 2023 - What is to be done now to ensure that the deadline is met?
  • Challenges and opportunities in moving towards digitalisation - It's time to start your run towards your digital transformation
  • Latest trends and developments in your supply chain
  • Smart packaging for pharma industries - Making packaging and labelling truly intelligent

Speakers
Key Speakers:

Anish Agarwal

Global Head of Analytics
Dr. Reddy's Laboratories

Gnanadev Gudipati

Associate Vice President
Natco Pharma

Rahul Mittal

Head Strategy - Emerging Markets
Dr. Reddy's Laboratories

Ram Kumar

Director MSTG
Cipla

Shakthi Nagappan

Director (Life Sciences & Pharma) & CEO
Telangana Life Sciences

Srinivasa Rao Sambangi

Sr. General Manager
Aurobindo Pharma

VIVEK JHA,

Head – Strategyand Operations, Global DrugDevelopment -India,
Novartis

Rajendar Burki, Ph.D.

Associate Vice President -R&D
Biological E Limited

Himal_P._Desai

Associate Vice President -R&D
Biological E Limited

Dr. Krishna Murthy Bhavanasi

Associate Vice President -R&D
Biological E Limited

Narendira Kumar

Senior General Manager & Site Quality Head

Dr. Nasir Ali

Associate Vice President
API-R&D Aurobindo Pharma

Rithesh Phalaksha

Digital solutions and Technology

Dr. Vishwas Sovani

Founder Director, Pharmawisdom
MD, DIM

Dr. Balaram Patro

CEO
GRK Research Laboratories Pvt. Ltd

Dr. BM Rao

C.E.O
QDOT Associates

Dr.Pawan Patinge

Founder
Academy of Analytical Instrumentation

Dr. K. Suresh Babu

Vice President- Quality Assurance
NATCO Pharma

Dr. Lakshmi Narayana

Associate Director, SCM
Aragen

R. Chandi Prasad

Head - Packaging Development, Commercial
Aurobindo Pharma Limited

Manjeeth Singh Rawat

Head of Supply Chain
CIS & Romania Markets

Dr. Satya Moturi

Proven Leader / Mentor
Who Should Attend?

The conference is an exclusive invite only event for senior delegates from the pharma industry. The profile of the attendees is as below:

  1. Pharma Leaders & Top CEO
  2. Technical Heads & Plant Heads
  3. Medical Heads & Senior Scientist
  4. Marketing & Strategy Leaders
  5. Quality Control & Clinical Research
  6. R&D Heads and Technocrats
  7. Engineering & Production Professionals
  8. Purchase & Packaging Professionals
  9. Regulatory Affairs Professionals

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