Regulatory Awareness Workshop
Summit Day One - US
Summit Day Two - EU
Summit Day Three – India, Japan and ROW
 
   
   
   
   
   
   
     
 

“It was a good interactive conference, where many of my queries were very well answered and resolved”

Shilpa Kotian , Manager Regulatory Affairs, Umedica Laboratories

 

“The conference was useful for us to understand the regulatory and business challenges in the global market for generics”

Pritam P Wade, Senior Manager Regulatoy Affairs , Themis Medicare

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DAY TWO – 1 MARCH 2012
   
08.30 Registrations and refreshments
   
09:00 Opening remarks from the Chair
   
EU Regulatory
   
09:10 Navigating a multitude of regulatory regimes across the EU to gain rapid approval and product registration in all European markets
 
  • Establishing the key differences between the European regulatory standards and FDA requirements for filing both DMF and generic applications
  • Clarifying the specific requirements for filing generic applications with respect to centralised and decentralised procedures in the EU
  • Clarifying the timelines involved in filing a generic application in the EU to ensure swift regulatory approval process
  • Examining effective strategies to overcome non-homogeneity challenges in the EU to minimise the complexities involved in multiple registration requirements
  Andrea Laslop,
Head of Institute Science and Information, Austrian Medicines and Medical Devices Agency,
AGES PharmMed, Austria
   
DMF FILING
   
Overcoming the challenges around DMF filing in the EU to ensure swift approval of Indian APIs
   
09:50 Qualifying the stability studies for different regions in the EU to ensure compliance with the European standards
 
  • Analysing the stability testing requirements with respect to temperature variations
  • Determining the stability protocols and submission requirements for DMF applications in the EU and overcoming specific challenges pertaining to critical documentation requirements
  • Clarifying the European guidelines around long-term stability to ascertain desired intervals of conducting tests
  Salma Michor,
CEO and Principal Consultant
Michor Consulting
   
10:30 Morning refreshments and networking
   
11:00 Determining the rigid specifications on impurity profiling requirements in the EU
 
  • Establishing the current EU requirements for impurity profiling and applying learnings from recent experiences to ensure compliance with respect to
    • Residual solvents
    • Metal catalysts
    • Reagents
    • Normal organic impurities
  • Determining the specific EU requirements pertaining to characterisation and quantification of impurities
  • Clarifying the evolving regulatory guidelines for genotoxic impurities to understand their optimal acceptance limit to ensure compliance with EU standards
  • Overcoming the specific challenges with respect to impurity testing at the raw material stage
  Rajni Jha,
 Senior General Manager, Drug Regulatory Affairs
Indswift Laboratories
   
11:40 Open discussion - Query Handling
 
    This is the perfect opportunity for delegates to bring their live challenges to the table around deficiencies faced during DMF filing and benefit from the combined experiences and know-how of the panel leaders as well as fellow delegates from the industry. Come armed with your most challenging questions and leave with a toolkit of practically implementable solutions pertaining to effective deficiency handling
   
GENERIC DRUG APPLICATION FILING
   
Identifying and overcoming the critical concerns around practical implementation of generic application filing procedure in the EU
   
   
12:10 Understanding and overcoming the challenges around registration of generic applications in the EU with practical case study insights – the importance of regulatory strategy and fulfilling European legislation on medicinal products
   
  Chemistry Review
 
  • Overcoming the challenges around impurity profiling at the drug product level
  • Troubleshooting genotoxicity regulatory requirements at the drug substance level
  • Understanding the stability submission requirements for drug products and understanding protocols specific to EU
   
  BE Review process
 
  • Understanding and overcoming the challenges around bioequivalence studies required to achieve swift regulatory approval
  • Clarifying the regulatory requirements specific to Pharmacokinetic and toxicology compliance
  • Evaluating stringent BE and toxicity requirements specific to EU standards
  • Determining various similarity and dissimilarity factors considered in bioequivalence review process
  • Overcoming challenges around clinical safety requirements
  • Highlighting the specific clinical trial data requirements to meet European regulatory standards and ensure compliance with GCP
   
  Labeling Review Process
 
  • Understanding the recent developments in labeling process in the EU to ensure safety compliance with respect to:
    • Indications
    • Positioning of drugs
    • Reference to the innovator
  • Determining dosage specific labeling challenges in the EU and formulating effective strategies to overcome these
  • Examining the specific requirements for safety labeling as per EU standards
  Rajeev Mathur,
Director – Regulatory Affairs,
Ranbaxy laboratories
   
  Steve Binysh,
Chief Consultant
Acta Pharma Services
   
13:20 Lunch and networking
   
14:20 Clarifying the variations guidelines in the EU and specific documents required to avoid any commercial implications
 
  • Understanding the post approval variation requirements in EU and identifying strategies to minimise cost and time involved
  • Determining specific documentation requirements in case of manufacturing or analytical changes
  Santosh Savarkar,
General Manager Regulatory
 Alembic Pharmaceuticals
   
15:00 Determining the pharmacovigilance and risk management requirements for Indian generic companies to efficiently handle post approval supplements in the EU
 
  • Understanding the pharmacovigilance regulations governing the products approved in the European markets
  • Identifying the specific documentation requirements with respect to preparing Aggregate Safety Reports
  • Analysing various post marketing risk management strategies to avoid any commercial implications at a later stage
  • Identifying various safety reporting software and complying with EU standards
  Rajkiran Jain,
Head International Regulatory Affairs
Zydus Cadila (Invited)
   
15:40 Afternoon refreshments
   
16:10 Working with the latest European regulations for hybrid applications to determine the most rapid route to gaining approval and product registration
 
  • Understanding the legal basis of filing a hybrid medicinal product in the EU
  • Determining the preclinical and clinical requirements for hybrid applications through practical case study insights
  • Getting to grips with the documentation intricacies to ensure the smooth transfer of critical information
  • Reviewing the specific regulatory approval bottlenecks and hurdles faced by innovative generic drug manufacturers
  Salma Michor,
CEO and Principal Consultant
Michor Consulting
   
16:50 Open discussion - Query handling
 
    This is the perfect opportunity for delegates to bring their live challenges to the table around deficiencies faced during generic drug application filing and benefit from the combined experiences and know-how of the panel leaders as well as fellow delegates from the industry. Come armed with your most challenging questions and leave with a toolkit of practically implementable solutions pertaining to effective deficiency handling
   
17:30 Close of Summit Day Two
   
   
 
 
 
 
 
 
     
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