Understanding Concepts and Regulatory Compliance Requirements for in Vitro-in Vivo Correlations

1. Global CompliancePanel Knowledge, a Way Forward… 2-day In-person Seminar: Understanding Concepts and Regulatory Compliance Requirements for in Vitro-in Vivo Correlations (IVIVC) and Predicting Plasma Drug Levels Baltimore, MD April 5th & 6th, 2018 9:00 AM to 6:00 PM Price Price:$1,495.00 (Seminar for One Delegate) Dr. Saeed Qureshi Register for 5 attendees Price: $4,485.00 You Save: $2,990.0 (40%)* $7,475.00 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. Register for 10 attendees Price: $8,222.00 You Save: $6,728.0 (45%)* $14,950.00 **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. 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.

2. 2-day In-person Seminar: Understanding Concepts and Regulatory Compliance Requirements for in Vitro-in Vivo Correlations (IVIVC) and Predicting Plasma Drug Levels Global CompliancePanel Agenda: Day One Day Two Lecture 1: Background information  Physiological aspect: Basic physiological concepts; systemic blood circulation; drug absorption, distribution, metabolism and elimination processes  Pharmacokinetics: Plasma drug concentration-time profiles, Tmax, Cmax, AUC, rate constant, half-life etc.)  Mathematical and statistical aspects for modelling/predictions: Do not need these, why? Explained! Morning Coffee Break Lecture 1: Relating in vitro & in vivo outcomes (IVIVC)  Why need IVIVC – overview  Suggested approaches (convolution/de-convolution)  Pharmacokinetic model based  Statistical/mathematical (linear system analysis) approach Morning Coffee Break Lecture 2: Relating in vitro & in vivo outcomes (IVIVC) [Continue]  Regulatory compliance requirements  IVIVC levels  Biopharmaceutic Classification System (BCS) and its inadequacy  Bio-waivers Lunch Break Lecture 2: In vivo testing  Drugs/medicines vs drug/medicinal products  Quality, safety and efficacy  Bioavailability  Bioequivalence Lunch Break Lecture 3: Relating in vitro & in vivo outcomes (IVIVC) [Continue]  Where did it (IVIVC) go wrong? Lecture 3: In vivo testing (continue)  A model study protocol and its requirements  Regulatory compliance requirements In vitro testing  Drug dissolution/release: Apparatuses, experimental conditions and designs  Regulatory compliance and pharmacopeial requirements  Difficulties in obtaining relevant and valid dissolution results  QC vs bio-/clinically relevant dissolution tests Afternoon Coffee Break IVIVC vs IVIVA (i.e. in vitro-in vivo association) Bringing it (IVIVC) back on track – do not need it, why? Explained.  What is needed - prediction of plasma blood levels? Afternoon Coffee Break Lecture 4: Predicting Plasma drug levels  DConvolution approach for converting dissolution results to plasma profiles.  Examples Overall summary Each section includes 15 to 30 minutes of Q&A, discussion and/or hands-on exercise as appropriate Lecture 4: In vivo testing (continue)  Discriminatory dissolution tests  Suggested solutions to address current deficiencies Alternate approaches Universal dissolution tester/tests Each section includes 15 to 30 minutes of Q&A, discussion and/or hands-on exercise as appropriate

3. 2-day In-person Seminar: Understanding Concepts and Regulatory Compliance Requirements for in Vitro-in Vivo Correlations (IVIVC) and Predicting Plasma Drug Levels Global CompliancePanel What You will get Group Participation 2 Attendees to get offer 10% 1 Learning Objectives 3 to 6 Attendees to get offer 20% 2 Participation certificates 7 to 10 Attendees to get offer 25% 3 Interactive sessions with the US expert 10+ Attendees to get offer 30% 4 Post event email assistance to your queries. Payment Option 5 Special price on future purchase of web based trainings. 1 Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link 6 Special price on future consulting or expertise services. 2 Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA 7 Special price on future seminars by GlobalCompliancePanel. 3 PO: Please drop an email to support@globalcompliancepanel.com or call the our toll free +1-800-447-9407 for the invoice and you may fax the PO to 302 288 6884 8 Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. 4 Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free +1-800-447-9407 for the wire transfer information 9 Networking with industry's top notch professionals Contact Information: Event Coordinator NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar Toll free: +1-800-447-9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com GlobalCompliancePanel www.globalcompliancepanel.com