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Who should attend Bioanalytical Methods and Good Laboratory Practices (GLP) - Essential Elements for Pre-Clinical Studies during development of Drugs
Managers and Scientists involved in Drug Development from Pharmaceutical and Biotech Industry, Contract Testing Laboratories performing toxicology and pharmacology studies, Personnel from Laboratories performing Bioanalytical methods
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Managers and Scientists involved in Drug Development from Pharmaceutical and Biotech Industry, Contract Testing Laboratories performing toxicology and pharmacology studies, Personnel from Laboratories performing Bioanalytical methods

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Seminar Summary:

This course will discuss in details the use and validation of bioanalytical methods. For clinical evaluation of drugs, bioanalytical methods and other methods, such as biological assays, immunochemical assays, etc. are used.  (see full course description)

 
 
 

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Training Course Syllabus:


Bioanalytical Methods and Good Laboratory Practices (GLP) - Essential Elements for Pre-Clinical Studies during development of Drugs

This course will discuss in details the use and validation of bioanalytical methods. For clinical evaluation of drugs, bioanalytical methods and other methods, such as biological assays, immunochemical assays, etc. are used. Clinical trials are conducted under the Good Clinical Practices (GCP) regulations, which mainly deal with conduct of clinical trials and provide not much information or guidelines for the methods used to test clinical samples. Bioanalytical methods used for clinical development are validated by the guidance provided by the regulatory agencies, but there is confusion in validation of biological assays, immunochemical assays, etc. used for clinical samples, as the ICH guidance for method validation (Q2R(1)) deals with methods used to test the product. This course will give an overview on the common practices and ways to validate methods used during clinical development of drugs.

Learning Objectives:

Upon completing this course the participants will understand:
Good Laboratory Practices (GLP) regulations and their distinction from the current Good Manufacturing Practices (cGMP) regulations
Myths and Regulatory Expectations about GLP
Achieving Compliance with GLP regulations
Challenges with complying with GLP regulations
Bioanalytical methods and their distinction from Biological methods
Validation of Bioanalytical Methods
Validation of Biological, Immunochemical and other Methods used to evaluation clinical samples
….much, much more

DAY 01(8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Good Laboratory Practices (GLP) – Introduction
History of GLP Regulations
Why these were developed?
Role in drug development
High Level Distinction between GLP and Good Manufacturing Practices (GMP)
Common Myths about GLP
Regulatory Basis for GLPs
Regulations, US (21 CFR 58), Europe (OECD), UK
Guidance Documents
Questions and Answers
Overview from Training Materials and Manual from WHO
Basic Elements of GLPs from 21 CFR 58
Subpart A, General Provisions
Subpart B, Organization and Personnel
Subpart C, Facilities
Subpart D, Equipment
Subpart E, Testing Facilities Operation
Subpart F, Test and Control Articles
Subpart G, Protocol for and Conduct of a Nonclinical Laboratory Study
Subpart J, Records and Reports
Subpart K, Disqualification of Testing Facilities
Organization and Personnel
58.29 – Personnel
58.31 - Testing facility management
58.33 - Study director
58.35 - Quality assurance unit
Facilities
58.41 - General
58.43 - Animal care facilities
58.45 - Animal supply facilities
58.47 - Facilities for handling test and control articles
58.49 - Laboratory operation areas
58.51 - Specimen and data storage facilities
Equipment
58.61 - Equipment design
58.63 - Maintenance and calibration of equipment
Testing Facilities and Operation
58.81 - Standard operating procedures
58.83 - Reagents and solutions
58.90 - Animal care
Test and Control Articles
58.105 - Test and control article characterization
58.107 - Test and control article handling
58.113 - Mixtures of articles with carriers

DAY 02(8:30 AM - 4:30 PM)

Protocol for and Conduct of a Nonclinical Laboratory Study
58.120 - Protocol
58.130 - Conduct of a nonclinical laboratory study
Records and Reports
58.185 - Reporting of nonclinical laboratory study results
58.190 - Storage and retrieval of records and data
58.195 - Retention of records
Disqualification of Testing Facilities
58.200 - Purpose
58.202 - Grounds for disqualification
58.204 - Notice of and opportunity for hearing on proposed disqualification
58.206 - Final order on disqualification
58.210 - Actions upon disqualification
58.213 - Public disclosure of information regarding disqualification
58.215 - Alternative or additional actions to disqualification
58.217 - Suspension or termination of a testing facility by a sponsor
58.219 - Reinstatement of a disqualified testing facility
BioAnalytical Methods
Introduction and their role
Distinction between Bioanalytical and Biological Methods
Validation of BioAnalytical Methods
Regulatory Guidance
FDA’s Guidance 2013
EMEA Guidance 2011
Chromatographic Methods and Ligand Binding Assyas
Reference Standards and Critical or Key Reagents
Selectivity
Accuracy
Precision and Recovery
Calibration Curve
Lower Limit of Quantification (LLOQ)
Upper Limit of Quantification (ULOQ)
Sensitivity
Reproducibility
Stability
Validated Method: Use, Data Analysis, and Reporting
System Suitability
Calibration Curves and QC
Overview of Validation of Methods Used for Clinical Samples
Ligand Binding Assays and Functional Assays
Reference Standard and Critical Reagents
Validation Characteristics
System Suitability and Quality Control

Seminar Summary:

This course will discuss in details the use and validation of bioanalytical methods. For clinical evaluation of drugs, bioanalytical methods and other methods, such as biological assays, immunochemical assays, etc. are used.  (see full course description)

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