Lect. No 1- 2009-10 Eli Solomon M.Sc 1 Regulation & Validation in Biotechnology & Pharma. Industry מרצה : אליעזר סולומון M.Sc, טלפון מס': 08-9405877 פקס.

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Lect. No Eli Solomon M.Sc 1 Regulation & Validation in Biotechnology & Pharma. Industry מרצה : אליעזר סולומון M.Sc, טלפון מס': פקס מס': פלאפון מס': דוא"ל: Lecturer: Eliezer Solomon Lecturer: Eliezer Solomon Phone No: No: Phone No: Fax No: Cellular No: מומחה לבדיקות אנדוטוקסין ומהנדס איכות. ניסיון של 26 שנות עבודה בתעשייה הביוטכנולוגית. חבר בASQ, ISQ, וIES -. יועץ, מרצה וכותב בתחומי האיכות.

Lect. No Eli Solomon M.Sc 2 נושאים - נושאים - Topics Sterile processing תהליכי עיקור Laboratories Pharmaceuticals, APIPharmaceuticals תרופות, מרכיבים פעילים Validation QualificationValidation Qualification Medical Device, QSR אביזרים רפואיים, דרישות מע' איכות FDA Design Control and Validation for Medical DeviceDesign Control and Validation for Medical Device CFR Packaging and Labeling European GMP

Lect. No Eli Solomon M.Sc 3 Regulatory– Terms & Definitions מונחים והגדרות API – Active Pharmaceutical Ingredients CFR – Code of Federal Regulations תקנות וחוקים פדראליים לגבי כל תחומי החיים מס' 21 קשור למנהל המזון והתרופות - FDA מהווה חלק ממחלקת שרותי בריאות הציבור 21 CFR ___ Department of Health and Human Services FDA – Food and Drug Administration מנהל המזון והתרופות 1. CDER - The Center for Drugs Evaluation and Research To assure that safe and effective drugs are available to the American people. How CDER works to accomplish this mission as it relates to new drug development and review.

Lect. No Eli Solomon M.Sc 4 New Drug Development Process- An interactive chart that provides an overview of the new drug development process, with an emphasis on preclinical research and clinical studies conducted by the drug's sponsor. פיתוח של תרופה חדשה תרשים רציף של תהליכי פיתוח המבוססים על מחקרים פרה קליניים וניסויים קליניים המבוקרים על ידי האחראים. כוללת 2 שלבים: IND ו - NDA מונחים והגדרות – Terms & Definition

Lect. No Eli Solomon M.Sc 5 Investigational New Drug (IND) Review Process- Investigational New Drug (IND) Review Process- Investigational New Drug (IND) Review Process- Investigational New Drug (IND) Review Process- An interactive chart that provides an overview of CDER's investigational new drug application process, including how CDER determines if the product is suitable for use in clinical trials. New Drug Application (NDA) Review Process- New Drug Application (NDA) Review Process- New Drug Application (NDA) Review Process- New Drug Application (NDA) Review Process- An interactive chart that provides an overview of CDER's new drug application review process, including how CDER determines the benefit: risk profile of a drug product prior to approval for marketing. מונחים והגדרות – Terms & Definition

Lect. No Eli Solomon M.Sc 6 2.CBER - The Center for Biologics Evaluation and Research המרכז להערכה מחקר של חומרים ביולוגים : חיסונים, דם ומוצריו, תאים ורקמות, ריפוי באמצעות גנים. Mission To ensure the safety, purity, potency, and effectiveness of biological products including vaccines, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury. Through our mission, we also help to defend the public against the threats of emerging infectious diseases and bioterrorism. מונחים והגדרות – Terms & Definition

Lect. No Eli Solomon M.Sc 7 תפקיד CBER להבטיח בטיחות, ניקיון, פעילות, אפקטיביות של מוצרים ביולוגים כמו חיסונים, דם, מוצרי דם, תאים, רקמות, וריפוי ע"י גנים למניעה, אבחנה, וטיפול במחלות הומאניות, תנאי תברואה או פציעות. בתוקף תפקידם גם הגנה על הציבור ממגיפות מדבקות וביו טרוריזם ב FDA קיימים משרדים נוספים העוסקים באספקטים נוספים של מזון ובריאות הציבור מונחים והגדרות – Terms & Definition

Lect. No Eli Solomon M.Sc 8 Safety Tests Preclinical R&D (GMP / GLP) Clinical Trial (GCP) NDA or Licensure Post-market surveillance Phase 1Phase 2 Phase 3 STAGES INVOLVED in REGULATING DRUGS מונחים והגדרות – Terms & Definition

Lect. No Eli Solomon M.Sc 9 The New Drug Development Process: Steps from Test Tube to New Drug Application Review

Lect. No Eli Solomon M.Sc 10 IND Phase 1 Initial Introduction into Human Dose Ranging Closely Monitoring Safety

Lect. No Eli Solomon M.Sc 11 Controlled Clinical Trials Effectiveness (Preliminary) Closely Monitoring Relatively Small Numbers (100) IND Phase 2

Lect. No Eli Solomon M.Sc 12 Evaluate Efficacy Larger Studies ( ) Controlled Pivotal(תוצאה עיקרית) IND Phase 3

Lect. No Eli Solomon M.Sc 13 מונחים והגדרות – Terms & Definition ICH = International Conference on Harmonization (ich.org) Technical requirements for demonstrating the quality, safety and efficacy of new medicines have been almost fully harmonised throughout the European Union, United States and Japan. via the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH).

Lect. No Eli Solomon M.Sc 14 ICH was launched in 1990 as a joint regulatory/industry project to make new pharmaceutical development and registration processes more efficient, in the interests of patients, public health, and cost-effectiveness, e.g. by preventing unnecessary duplication of clinical trials in humans and minimizing animal testing. גוף משותף לממשלות ולתעשייה לייצור תרופה חדשה ורישומה שיהיה יעיל יותר, בעל עניין לחולים, לבריאות הציבור וזול. כל זאת על ידי מניעת כפילויות של ניסויים קליניים והקטנת מספר חיות הניסוי מונחים והגדרות – Terms & Definition

Lect. No Eli Solomon M.Sc 15 מונחים והגדרות – Terms & Definition By the end of the first phase of ICH activity, which ended at the fourth conference (ICH 4, Brussels, July 1997), tripartite guidelines had been finalised on 45 harmonisation topics, in four broad categories: “ Quality” topics, which relate to chemical and pharmaceutical quality assurance (e.g. stability testing and impurity testing); “Safety” topics, which relate to in-vitro and in-vivo pre-clinical studies (e.g. carcinogenicity testing and genotoxicity testing); “ Efficacy” topics, which relate to clinical studies in human subjects (e.g. dose response studies and good clinical practice); “Multidisciplinary ” topics, i.e. those that do not fit uniquely into any of the above categories (e.g. medical terminology and electronic standards for the transmission of regulatory information).

Lect. No Eli Solomon M.Sc 16 QSR – Quality System Regulations: According to FDA is Part of 21 CFR 807, 820, The FDA defines process validation as follows: Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. מונחים והגדרות – Terms & Definitions

Lect. No Eli Solomon M.Sc 17 הגדרת המושג תיקוף Validation (מתוך ת”י נספח מתורגם) 3.24 הליך מתועד לצורך השגה, רישום וניתוח של התוצאות, הנדרשות כדי לקבוע שתהליך יניב בעקביות מוצר המתאים למפרטים שנקבעו מראש.

Lect. No Eli Solomon M.Sc 18References FDA HOME PAGE ICHWHO