Agenda

08:30 AM SUMMIT REGISTRATION & MORNING REFRESHMENTS
09:30 AM OPENING REMARKS BY LEX WITNESS
09:45 AM THE SUMMIT CHAIR’S ADDRESS – DEBOLINA PARTAP, VP & GENERAL COUNSEL, WOCKHARDT GROUP
10:00 AMTHE INDIAN PHARMA REGULATORY RIDES – ARE WE READY FOR 2020?

THE FDC SAGAS

  • The 344 FDC Ban – Lessons & Learnings – Managing FDC related litigation & court matters
  • India as an FDC Market – Getting Future Ready – Overlaps between FSSAI & CDSCO Reins – The Classic Case of ORS

PRICING OF DRUGS – WHOSE CAP IS IT ANYWAY?

  • The NPPA Whips on Drugs & Medical Devices – Impact on R&D and Manufacturing
  • The Medical Devices Rules, 2017 Industry Implications And Action Required

CREATING A 100% COMPLIANT BUSINESS ENVIRON

  • USFCPA – Impact Assessment
  • Importance of e-Discovery as a Tool, Litigation Risks wrt e-Discovery Preparedness
  • Global Employment related Compliance Challenges – Are You Prepared Enough?
  • Whistle Blower Protection | Managing Forensic Investigations | Enterprise Risk Management | Audit Lifecycle Management
  • Good Manufacturing Practices – Quality Control vs. Business Margins
  • Alliance for Integrity – A Self-Regulatory Drive

UCPMP & MCI GUIDELINES

  • Prescription Guidelines – Capping on Sampling of Drugs
  • Power to Pharmacists – Salts Vs. Drug Names – UCPMP Code – on its way to become Mandatory?

COMPETITION LAW

  • CCI Warning to Druggists & Chemists Associations
  • Interplay between Regulatory and Competition for pricing of products – Merger Notifications to CCI

DEMYSTIFYING THE BIOSIMILARS

  • Defining Number of Trials in case of Biosimilars – Lack Legislative Clarity for Biosimilars
  • The 180-Day Post-Licensure Notice for Biosimilar Litigation – CDSCO Revised Guidelines On Similar Biologics

CLINICAL TRIALS

  • Demand for Compensations for the Affected – Justified Enough?
  • Recent Regulatory Changes – A leg up to the Indian Clinical Trials Industry?

THE TOUGH INDIAN PHARMA TURF 2017

  • GST impact on domestic business and its normalisation – Update on USFDA issues plaguing several companies
  • Continued pricing erosion in US business with consolidation of buyers
  • increased competition and growth in emerging markets after stabilisation of currencies

THE GLOBAL GAMES

  • Combating USFDA Pressures
  • FDI Fevers in Brownfield Projects – Standard Operating Procedure ( SOP ) for processing the FDI proposals by DIPP
  • Setting up Globally Compatible Regulatory Standards – Challenges facing seamless exports of Indian Drugs
  • Facilitating Import of Foreign Drugs – Concept of GDUFA – Disallowance of Reverse Engineering

& MORE – NICE TO KNOW

  • Fair Remuneration for Compulsory Licensing – Amendments to The Legal Metrology (Packaged Commodities) Rules, 2011
  • Industry’s Concern Over issue of Growing expired drugs with no set rules – Indian Health Care Payment Rates – Assessment
11:30 AM NETWORKING AND REFRESHMENT BREAK
12:00 NOONTHE DIGITAL WAVE – TECHNOLOGICAL ADVANCEMENTS & PREPAREDNESS
  • The Growing Role of Automation in the Pharmaceutical Industry
  • Use of Artificial Intelligence for Drug Discovery
  • Cyber Security – Proactive Measures for Ransomware Attacks
  • Need to strengthen know-how in regulations including cyber security & anti-bribery
  • Data Driven Insights – Criticality for Drug Value Assessment & Decision Making
  • Developing Integrated Clinical Research Frameworks & Big Data Analysis
  • Devising a Growth Strategy by Big Data Analysis – Data Protection & Privacy – Eliminating Chances of Breach of Confidentiality
  • Securing Patient Data – Leakage of e-prescription information
  • FDI in Pharma Tech and e-Pharma
  • e-Pharmacy – Dire Need to Cover the Black Hole of Legislation & Regulatory Affairs?
  • e-Pharma Liabilities – Intermediary Vs. Aggregator – Probable e-Pharmacy Models – Inventory & Marketplace
  • Cloud Computing – Legal & Regulatory Challenges w.r.t Indian Pharma Sector
  • Driving ROI & Risk Mitigation through effective Contract Lifecycle Management
  • Can Enterprise Businesses outperform rivals by leveraging Artificial Intelligence in their Contracting processes?
  • Can AI+Intelligent Bot enabled Contract Management be the best ally of a GC today?
01:15 PM NETWORKING LUNCH
02:15 PM IPR & THE INDIAN PHARMA REGIME
  • Combating Counterfeiting Efforts
  • Demand for Anti-Counterfeiting Service Agencies
  • Anti-Counterfeiting Advisory
  • Patent Issues – Indian Standpoint Vs. Global Benchmarks
  • Patent Wars – Opposition & Litigation
  • Survival of the Generics
  • ANDA Licenses – Blindspot for India
  • Role of IPR in ANDA Litigations
  • Trade Secret Policies Vs. Patents – Pros & Cons
  • Injunction Vs. Licenses – How would R&D Furnish?
  • Critical e-Discovery Mandates in IPR
  • WIPO Alternative Dispute Resolution (ADR) for Life Sciences
  • Need of Incentivization for Research to Foster IPR Environ
  • Patents & Data Exclusivity
  • Combating Trademark Litigation
  • Bolar Exemption in Indian Patent Law
  • Patent Term Extension & Non-Patent Exclusivities for Pharmaceuticals – Much Needed?
  • Setting up of The IP Exchange in India
  • Drug Re-purposing & Associated Patentability Scope
03:45 PM NETWORKING AND REFRESHMENT BREAK
04:15 PM THE INDIAN PHARMA MARATHON – 3 POWER PACKED DISCUSSION GROUPS TO CHOOSE FROM

A 60 minute power packed set of deliberations and discussions where the audience would be segregated into 3 roundtables led by respective roundtable leaders who will share their respective discussion insights individually. To conclude the marathon, a session chair will draw key learnings and takeaways basis all 3 roundtable discussion insights. The 3 roundtable discussion topics that the audience may choose to be a part of are as follows;

– Creating Value through Smart Contracts
– Global Bestpractices to Combat Counterfeiting
– Streamlining Strategies & Creating a Roadmap – Pharmaceutical Pricing in India

05:15 PM GALA LUCKY DRAW FOLLOWED BY SUMMIT CLOSING REMARKS

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