Track 2

 

IMPURITY PROFILING CONFERENCE

OVERVIEW
Impurity Profiling Conference will focus on details delineated in the ICH M7 and Q3D guidelines and elaborate on the challenges that industry is experiencing when attending elemental and genotoxic impurities in drug substances and drug products.
KEY OBJECTIVES
  • To Gain In-Depth Guidance on the ICH M7 and Q3D Guidelines and its Implementation
  • To Learn to Identification and Quantification of Impurities at the Right Level
  • To Avoid Deficiencies and Rtrs (Refuse To Receive) by Adequately Attending to Potential Mutagenic Impurities
  • To Understand the Risk Assessment and Control Strategies for Mutagenic Impurities
  • To Hear About Real Time Case Studies on Impurity Profiling
SPEAKERS

Dr. BM Rao

VP & Head – Analytical Science & Technology & CQC

Dr. Reddy's Laboratories

Dr. Atul Awasthi

Director - GTS MSAT AS

Pfizer

Dr. Vandana Singh

Director in Advanced Characterisation Laboratories

Dr. Reddy’s Laboratories Ltd.

DAY 1
08:00 REGISTRATIONS
09:00 Plenary Session
11:30 Opening Address
11:35 Panel Discussion: Examining and Analyzing Current Trends in Impurity Profiling and its Scope in Depth
  • Panel Discussion: Examining and Analyzing Current Trends in Impurity Profiling and its Scope in Depth
  • Understanding the latest methodologies and techniques for efficient identification, quantification and characterization of mutagenic and elemental impurities
  • Risk assessment and control strategies for mutagenic and elemental impurities

Moderator:

Dr. Atul Awasthi, Director, GTS MSAT AS , Pfizer

Panelists:

Dr. Vandana Singh, Director, Dr. Reddy's Laboratories

Dr. BM Rao, VP & Head – Analytical Science & Technology & CQC, Dr. Reddy’s Laboratories

Dr. Kailash Asati, Global Senior Stability Expert, Novartis Healthcare

12:15

Stability and Forecasted Shelf Life of Drugs

Dr. Kailash Asati, Global Senior Stability Expert, Novartis Healthcare Pvt Ltd.

LUNCH & NETWORKING
14:00 Elemental Impurity Profile Overview
  • Elemental Impurities- Guidelines and Measuring
  • Risk Assessment
  • FDA Perspective and Expectations for Control of Elemental Impurities in Drug Products

Dr. BM Rao, VP & Head – Analytical Science & Technology & CQC, Dr. Reddys Laboratories

14:40 Overview on ICH Q3D, Delamination and Leachables in Pharmaceuticals
  • Implementation of ICHQ3D and the challenges for Pharma industry
  • Guidelines
  • Applications of Options I, II and III
  • Control strategy
  • Delamination – Causes and screening and predictive studies
  • Leachables – Cause/ concerns and control
  • Tips on troubleshooting

Dr. Vandana Singh, Director, Dr. Reddy's Laboratories

15:20 Risk Assessment and Control of Elemental Impurities
  • Current challenges in implementation and guidance on constructing solid risk assessments
  • Identification and evaluation of the elemental impurities as per regulatory expectations
  • Tools and technologies to control elemental impurities
  • Life cycle approach to control elemental impurities
  • Overview on use of data and method validation for current and future risk assessments
  • Case study based on sources of impurities

Dr. Atul Awasthi, Director - GTS MSAT AS, Pfizer

HIGH-TEA & NETWORKING
16:30 Genotoxic Impurity Profile Overview
  • Classification of impuriti
  • Regulatory expectations to control genotoxic impurities in drug substances and drug products
  • Identification and quantification of genotoxic impurities
  • Case Study

Dr. Atul Awasthi, Director - GTS MSAT AS, Pfizer

17:30 Closing Remarks by the Chairperson
END OF DAY ONE

 

DAY 2
08:00 REGISTRATIONS
09:45 Opening Remarks
10:00 Extractables and Leachables
  • Importance of Extractables and Leachable Studie
  • Current regulatory scenarios and the recent updates
  • Safety qualification of Extractables and Leachables

Madhu Sudhan Rao Rachakonda, Manager, Hetero Drugs Ltd

Vinod Kansal, President, Amoli Organics

Arvind Kumar, Vice President Analytical R&D, Mylan

10:45 Genotoxic Impurities in Pharmaceuticals
  • Understanding the analytical procedures to assess the risks involved and the probable actions
  • Techniques to screen the mutagenic impurities at the right stage
  • Right strategies to control these impurities

Arvind Kumar, Vice President Analytical R&D, Mylan

NETWORKING BREAK
12:00

The Story of Genotoxic Impurities in Sartans and their Control Strategy

Vinod Kansal, President, Amoli Organics

13:00 In Silico Assessment of Genotoxic Impurities Under the ICH M7 Guideline
LUNCH & NETWORKING
15:00 Drug Product Quality and Impact of Extractable & Leachable Impurities
16:30 CLOSING REMARKS FOLLOWED BY HIGH-TEA & NETWORKING
END OF DAY TWO

for detailed agenda download the brochure