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Event Details


Understanding in Vitro-in Vivo (IVIVC) Correlations Seminar 2018

Regulatory Compliance Requirements

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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


Overview:Let us start with a simple question, why would anyone need an IVIVC and prediction of plasma drug levels. The simple answer is that it is the only scientific tool available to the formulators to develop pharmaceutical products such as tablet and capsule accurately and efficiently. Preparing a formulation/product for safety and efficacy assessment and then for general use, it has to be ascertained that a product is capable of delivering the drug in humans as expected. In addition, after developing a product, a relevant in vitro test in the only tool available to establish quality, and extension safety and efficacy, of the product thus link of such test to IVIVC is crucial. Therefore, consideration of IVIVC is perhaps the most critical step in the manufacturing of pharmaceuticals. The regulatory authorities worldwide require practicing and implementation of IVIVC as an integral part of drug applications reviews for product marketing approvals. However, unfortunately, development of IVIVC and its applications have not been as successful as anticipated, more accurately failed, thus leaving the manufacturers and regulatory authorities alike in an extremely confused state for assessing or establishing quality of pharmaceutical products.Experience of the past 30+ years working in the regulatory environment provided a unique insight of the issues currently facing the industry and regulatory authorities in this regard. This seminar will describe the issues and the reasons which have caused and/or causing the issues. In short, it is the misunderstanding of the scientific concepts as well as the use and requirements of inappropriate experimental conditions and the study designs which are causing the current problems. This seminar will provide simple and practical solutions to address the issues by explaining in detail the underlying scientific concepts and principles which are often missed or overlooked. Realizing that it is a multi-subject exercise thus details and discussions will be provided in an extremely simple language so that attendees with different backgrounds would be able to follow the content for which they might not have prior training or experience such as physiology and mathematics.Why should you attend:This seminar will focus on:• Highlighting the current misunderstandings of the concepts which lead to disappointments in successful application of IVIVC in particular from regulatory compliance perspective.• In vitro and in vivo associations which have often been mistakenly presented as IVIVC resulted in lack of anticipated success of IVIVC and its applications.• The use of non-validated testers and experimental conditions for in vitro product characterization.• Addressing the above mentioned shorting comings by suggesting scientifically valid yet simple solutions.• An extremely simple concept with hands-on exercises will be described for predicting plasma drug concentration-time profile from drug dissolution results.Areas Covered in the Session:• Physiological aspect• Relevant pharmacokinetics• Quality, safety and efficacy aspects of drugs/medicines vs drug/medicinal products• Bioavailability/ bioequivalence• In vivo and in vitro testing• Relating/linking in vitro & in vivo outcomes (IVIVC)• Biopharmaceutic Classification System (BCS)Location: Baltimore, MDDate: April 5th & 6th, 2018Time: 9:00 AM to 6:00 PMVenue: WILL BE ANNOUNCED SOONPrice:Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)Until March 10, Early Bird Price: $1,295.00 From March 11 to April 02, Regular Price: $1,495.00Contact us today!NetZealous LLC DBA Toll free: +1-800-447-9407Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.comRegistration Link - Follow us on LinkedIn: us our Facebook page: us on Twitter:


Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird) Until March 10, Early Bird Price: $1,295.00 From March 11 to April 02, Regular Price: $1,495.00


John Robinson

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