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?
- 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
- 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
- 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?
- 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
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