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Pre-clinical or non-clinical studies are required during drug development to evaluate safety in animals (toxicology) and pharmacokinetics and bioavailability (pharmacology) of drugs prior to initiating the clinical development of a drug. These studies must be performed following the Good Laboratory Practices (GLP) regulations, specified by the US FDA or principles and guidelines developed by the Organisation of Economic Co-operation and Development (OECD). Regulations for the GLP, specified in 21 CFR 58, related guidelines, including “questions and answers” documents, a training handbook and training manuals developed by the World Health Organization (WHO) are available to clarify the regulatory expectations with a view to assisting the sponsors of drugs and contract testing laboratories performing toxicology and pharmacology studies in complying with these regulations. Despite these guidance documents and training materials, GLP regulations are one of the most commonly misunderstood regulations for drug development and manufacturing operations with a number of myths about GLPs. This course will explain various elements of GLPs in detail with a view to comply with the regulations and Law as per regulatory requirements and expectations.

Analytical methods are required in evaluating pharmacology of drugs (pharmacokinetics and bioavailability) in animals and humans. The regulatory agencies in the US and Europe have termed these methods as bioanalytical methods. Most of these methods are analytical methods, but these methods when used to detect or quantify the drug in biological fluids or tissues have been referred as bioanalytical methods. Often these methods are confused with biological methods or bioassays commonly used in testing and characterization of biological products or biologics and also used in evaluating functionality (for example, Immunogenicity) of drugs and biologics (functional assays). Regulatory agencies have issued guidelines for validation of bioanalytical methods.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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.

Throughout the course, relevant examples with regard to meeting regulatory expectations will be discussed.

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

Who will Benefit:

  • 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
  • Personnel from Laboratories testing Clinical samples for determining efficacy of drugs and biologics
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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
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Rajesh K Gupta

Rajesh K Gupta
Visionary Scientific and Compliance Consultant, Biologics Quality & Regulatory Consultants, LLC

Rajesh K. Gupta has a Ph.D. in microbiology and is the Principal Consultant at the Biologics Quality & Regulatory Consultants, LLC. He has more than 35 years' experience in the development, production, testing and regulation of biologics, working at both the regulatory agencies and the industry.

At FDA, CBER, he was a Deputy Director and the Lab Chief in the Division of Biological Standards and Quality Control, managing lot release of biological products, regulatory reviews of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods.

In his previous jobs, he worked at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH), in the USA and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in sterility assurance for biological products, adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development and validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and has made numerous presentations at scientific and regulatory meetings.

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