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Pharmacokinetics and Biopharmaceutics for Regulatory Compliance 2018

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Baltimore, MD

Baltimore, MD 21206

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Course "Pharmacokinetics and Biopharmaceutics for Regulatory Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


This seminar is developed with a series of learning objectives in mind. After attending the seminar the attendees should be able to:

  1. Clearly understand the basic concepts of pharmacokinetics and biopharmaceutics.
  2. Use raw data and derive the pharmacokinetic models and parameters describing the processes of drug absorption, distribution, and elimination.
  3. Apply biopharmaceutics for the products development and manufacturing.
  4. Practice in-class hands-on exercises to understand and apply the studied concepts (a computer with excel software would be required).
  5. Acquire knowledge of related regulatory/compliance requirements and guidance documents

Why you should attend:

Pharmaceutical product developments and assessments require extensive testing to establish quality, safety and efficacy of the products. Such testing is conducted by laboratory facilities mostly analytical (internal as well as external to the manufacturers) which often lack needed pharmacokinetics and biopharmaceutics expertise/understanding leading to poor study or experimental design followed by inaccurate interpretation of results. Therefore, current practices are not only causing significant frustration and wastage of time and resources within the industry and regulatory authorities but also delays in product approvals. This seminar is designed to address these deficiencies. The attendees will have clear understanding of the underlying science so that they would be able to design/evaluate the experimental studies appropriately followed by efficient and accurate interpretation of the results.

Areas Covered in the Session:

  • Physiological Concepts
  • Drug metabolism
  • Analytical methods)
  • Pharmacokinetics
  • Compartment models
  • Absorption, distribution, metabolism, elimination
  • Bioavailability
  • Biopharmaceutics
  • Drug dissolution testing
  • Routes of drug administrations
  • Branded and generic products
  • Regulatory guidance and requirements

Who will benefit:

Regulatory affair personnel, bench chemists/analysts, supervisors, managers, directors or vice presidents in pharmaceutical manufacturing facilities, including laboratories and associated contract organizations, of innovator and generic companies for human and animal products, in the following areas:

  • Pharmaceutical Development
  • Setting up analytical methods (pharmacopeial, regulatory or in-house developed)
  • R & D, both analytical and formulation
  • Project Management
  • Quality Control
  • Quality Assurance
  • Regulatory Affairs


Day 1 Schedule

Lecture 1:

Background Information -1:

  • Drugs/Medicines and Drug/Medicinal Products
  • Physiological Concepts
  • Drug disposition/Metabolism

Q&A and hands-on practice (exercise)

Lecture 2:

Background Information - 2:

  • Review of Mathematical Fundamentals
  • Rates and Orders of Reactions
  • Analytical Methods (Development and Validation)

Q &A and hands-on practice (exercise)

Lecture 3:

Pharmacokinetics - 1

  • One Compartment Model
  • Multi Compartment Models
  • Absorption
  • Distribution
  • Metabolism (Hepatic/Liver)

Q &A and hands-on practice (exercise)

Lecture 4:

Pharmacokinetics – 2

  • Elimination
  • Plasma drug-time profile
  • Parameters (cmax, tmax, AUC)
  • Bioavailability

Q &A and hands-on practice (exercise)

Day 2 Schedule

Lecture 1:

Biopharmaceutics - 1

  • Routes of drug administration
  • Oral products and GI tract absorption mechanism
  • Immediate/fast/conventional-Release product
  • Modified-Released Products
    • Delayed-Release Products
    • Controlled/slow-Release Products

Q &A and hands-on practice (exercise)

Lecture 2:

Biopharmaceutics – 2

  • Bioequivalence
  • In vitro (drug dissolution) testing
  • Branded vs Generic Products

Q &A and hands-on practice (exercise)

Lecture 3:

Compliance Requirements - 1

  • Regulatory Guidelines or Guidance Documents
  • Analytical

Lecture 4:

Compliance Requirements - 2

  • Regulatory Guidelines or Guidance Documents
  • Biopharmaceutics


Saeed Qureshi

Dr. Qureshi has extensive (30+ years) working experience, as a research scientist, with a regulatory agency (Health Canada). He is an internationally known expert on the subject and maintains a full command in the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products. Specifically: (1) Quality assessment of pharmaceutical products based on pharmacokinetic studies (e.g. bioavailability/bioequivalence) in humans and animals, including validation of in vitro results with in vivo (bioavailability) studies. (2) In vitro drug release characterization of pharmaceutical products in particular oral and dermal using dissolution and/or diffusion (absorption/penetration through skin) techniques. (3) Analytical methods development/validation for drug disposition evaluation in humans and animals using chromatographic (e.g. HPLC, GC, TLC) and spectroscopic (e.g. UV, MS) techniques. (4) Data analysis using sophisticated (SAS) and general-purpose (e.g. MS Excel) software.

Dr. Qureshi has extensively published in peer-reviewed journals and given numerous national and international presentations on the subject. Dr. Qureshi is very well known for his innovative but simple and practical ideas. Since 2010, he has been contributing and moderating a weblog (www.drug-dissolution-testing.com) which has become a popular source of new and thought provoking ideas for addressing the issues of product evaluations.

Since 2015 Dr. Qureshi has been working as an independent consultant. A detailed description of his expertise and the services he provides may be obtained from the website (www.pharmacomechanics.com).

Location: Baltimore, MD Date: April 2nd & 3rd, 2018 and Time: 9:00 AM to 6:00 PM



Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until February 28, Early Bird Price: $1,295.00 From March 01 to March 31, Regular Price: $1,495.00

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As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

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Baltimore, MD

Baltimore, MD 21206

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