PRESENTED BY      Devesh Sharma M.Pharm-DRA [email_address]   PRESENTATION  ON COMPARATIVE STUDY OF DOSSIER COMPILATION & ...
CONTENTS <ul><li>Aim & Objective of work </li></ul><ul><li>Introduction </li></ul><ul><li>Literature review </li></ul><ul>...
AIM & OBJECTIVE <ul><li>Comparative study of dossier compilation &  </li></ul><ul><li>submission process in USA, Europe & ...
<ul><li>Dossier is a file document submitted for  the approval of  drug product. </li></ul><ul><li>It is submitted in form...
<ul><li>Generic drug approved under  </li></ul><ul><li>ANDA submission (USA)  </li></ul><ul><li>MAA submission (EU) </li><...
Orange book -Approved drug product with therapeutic equivalence evaluations , published by the FDA (CDER) Hatch-Waxman act...
<ul><li>Martin s. lipsky,   in 2001, The drug approval process </li></ul><ul><li>Food and Drug Administration (FDA) is res...
<ul><li>Jaime R hornecker,in 2009, Generic drugs: history,  </li></ul><ul><li>approval process and current challenges </li...
<ul><li>Chow sc ,  2010, Statistical assessment of biosimilar  </li></ul><ul><li>products </li></ul><ul><li>Biological pro...
REGULATORY GUIDELINES FOR DOSSIER SUBMISSION IN USA
Dossier is submitted in CTD format. <ul><li>CTD format  </li></ul><ul><li>Aim   </li></ul><ul><li>To harmonize the structu...
Regional Admin Information Module-1  Nonclinical overview Clinical overview Clinical Summary Quality  overall  summary Qua...
<ul><li>The CTD is organized into five modules: </li></ul><ul><ul><li>Module 1 is region specific. </li></ul></ul><ul><ul>...
1.1 Table of Contents of the Submission  1.2 Documents Specific to Each Region (for  example, application forms,prescribin...
Module 2. CTD Summaries Begin with a general introduction to the pharmaceutical (its pharmacological class, mode of action...
2.4 Non-clinical Overview  2.5 Clinical Overview  2.6 Non-clinical Written and Tabulated Summaries 2.7 Clinical Summary  M...
Module 5. Clinical Study Reports  5.1 Table of Contents of Module 5  5.2 Tabular Listing of All Clinical Studies  5.3 Clin...
REGULATORY GUIDELINES FOR DOSSIER SUBMISSION IN  Europe
<ul><li>Pharmaceutical companies of EU are use three approval procedures  to market their pharmaceuticals </li></ul><ul><l...
Draft decision of the commission
<ul><li>Decentralized procedure- </li></ul><ul><li>An applicant can go directly to a national  </li></ul><ul><li>marketing...
 
Mutual recognition procedure (MRP)- Used in order to obtain marketing authorizations in several Member States where the me...
DIFFERENCE  b/w  eu & fda
<ul><li>EU  </li></ul><ul><li>Multiple agencies </li></ul><ul><ul><li>European Medicines Evaluation Agency  </li></ul></ul...
<ul><li>EU   </li></ul><ul><li>Multiple registration procedures </li></ul><ul><ul><li>Centralized </li></ul></ul><ul><ul><...
EU TSE /BSE study data is required Braille code is required on labeling FDA TSE /BSE study data is not  required Braille c...
REGULATORY GUIDELINES FOR DOSSIER SUBMISSION IN INDIA
<ul><li>Drug & Cosmetic Act 1940 & Rules 1945 </li></ul><ul><li>Regulates the import, manufacture,  </li></ul><ul><li>dist...
<ul><li>CDSCO </li></ul><ul><li>A licensing authority for approval of new drug  </li></ul><ul><li>proposed to be imported ...
 
COMPARATIVE STUDY OF DOSSIER SUBMISSION PROCESS OF DRUG PRODUCT IN  USA, EU, India
S.No. Requirements USA EU India A. ADMINISTRATIVE 1. Application ANDA MAA MAA 2.  Debarment Certification Required NA NA 3...
S.No. Requirement USA EU India 2. Assay 90-100% 95-105% 90-110% 3. Disintegration Not required Required Required 4. Color ...
S.No. Requirement USA EU India D. STABILITY 1. No. of batches 01 02 01 2.  Condition 25/60: 40/75 25/60: 40/75 30/35; 30/7...
S.No. Requirement USA EU India E. BIOEQUIVALENCE 1 CRO Audited by FDA Audited by MHRA CDSCO 2. Reserve sample 5 Times the ...
<ul><li>SUMMARY  </li></ul><ul><li>In this presentation we did individually study about the rule & regulations which are f...
And in last we did the comparative study.  This comparative study of dossier compilation given a brief idea about the diff...
<ul><li>Conclusion   </li></ul><ul><li>Significantly reduces the time and resources  </li></ul><ul><li>needed to compile a...
<ul><li>Provide for a scientifically sound means of  </li></ul><ul><li>establishing the quality, safety and efficacy of  <...
<ul><li>Generic drugs, website- www.wikipedia.org/wiki/generic-drug. </li></ul><ul><li>2. CTD Guidelines map (ICH,EMEA AND...
7. EMEA and Overview of the Centralised Procedure, website-  www.who.int/entity/vaccine_research/diseases/influenza/Celis....
13. Filiz hinchal, An introduction to safety issues in  biosimilars/follow-on biopharmaceuticals, Jmed cbr 7,1 sept.  2009...
18.Revision History Module 1 Administrative informationwebsite-  www.fda.gov/downloads/Drugs/.../UCM163175.pdf 19.FDA Deba...
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Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India.

  1. 1. PRESENTED BY Devesh Sharma M.Pharm-DRA [email_address] PRESENTATION ON COMPARATIVE STUDY OF DOSSIER COMPILATION & SUBMISSION PROCESS OF DRUG PRODUCT IN USA, EUROPE & INDIA
  2. 2. CONTENTS <ul><li>Aim & Objective of work </li></ul><ul><li>Introduction </li></ul><ul><li>Literature review </li></ul><ul><li>Regulatory guidelines for dossier submission in USA </li></ul><ul><li>Regulatory guidelines for dossier submission in Europe </li></ul><ul><li>Difference b/w EU & FDA </li></ul><ul><li>Drug product approval process in India </li></ul><ul><li>Comparative study of dossier submission process of drug product in USA, EU & India </li></ul><ul><li>Summary & conclusion </li></ul><ul><li>References </li></ul>
  3. 3. AIM & OBJECTIVE <ul><li>Comparative study of dossier compilation & </li></ul><ul><li>submission process in USA, Europe & India </li></ul><ul><li>To understand the regulatory guidelines in </li></ul><ul><li>drug approval procedure </li></ul><ul><li>To understand the importance of regulatory </li></ul><ul><li>guidelines </li></ul><ul><li>Comparative study of regulatory guidelines of </li></ul><ul><li>FDA, EMEA & MHFW </li></ul>
  4. 4. <ul><li>Dossier is a file document submitted for the approval of drug product. </li></ul><ul><li>It is submitted in form of CTD. </li></ul><ul><li>CTD is a harmonized format (template) for presenting data in the ICH regions </li></ul><ul><li>Generic drug product is comparable to an innovator drug product- </li></ul><ul><ul><li>In dosage form </li></ul></ul><ul><ul><li>Strength </li></ul></ul><ul><ul><li>Route of administration </li></ul></ul><ul><ul><li>Quality </li></ul></ul><ul><ul><li>Use etc </li></ul></ul>INTRODUCTION
  5. 5. <ul><li>Generic drug approved under </li></ul><ul><li>ANDA submission (USA) </li></ul><ul><li>MAA submission (EU) </li></ul><ul><li>Generic drug applications are termed as “ Abbreviated ” </li></ul><ul><li>RLD- An approved drug product to which new generic versions are compared to show that they are bioequivalent. </li></ul>
  6. 6. Orange book -Approved drug product with therapeutic equivalence evaluations , published by the FDA (CDER) Hatch-Waxman act 1984 eliminates the costly clinical trial for approval of generic drugs. CDSCO is regulatory authority for the approval of new drugs proposed to be imported. (India)
  7. 7. <ul><li>Martin s. lipsky, in 2001, The drug approval process </li></ul><ul><li>Food and Drug Administration (FDA) is responsible for assuring </li></ul><ul><li>that foods and cosmetics are safe and that medicines and </li></ul><ul><li>medical devices are both safe and effective. </li></ul><ul><li>Welage L.S., in 2001, Understanding scientific issues </li></ul><ul><li>embedded in the generic drug approval process </li></ul><ul><li>Regulations regarding bioequivalence have been in place for </li></ul><ul><li>more than 20 years, controversies over bioequivalence continue </li></ul><ul><li>to arise. </li></ul><ul><li>Lionberger RA., in 2008, Opportunities for generic drug </li></ul><ul><li>development </li></ul><ul><li>FDA's critical path initiative documents have focused on the </li></ul><ul><li>challenges involved in the development of generic drugs. </li></ul><ul><li>Peters JR., in 2009, Generic drugs-safe, effective and </li></ul><ul><li>affordable dermotol </li></ul><ul><li>The history and evolution of the process for generic drug </li></ul><ul><li>evaluation and approval in the United States, with emphasis on </li></ul><ul><li>locally acting dermatologic products. </li></ul>REVIEW OF LITERATURE
  8. 8. <ul><li>Jaime R hornecker,in 2009, Generic drugs: history, </li></ul><ul><li>approval process and current challenges </li></ul><ul><li>According to the FDA, a generic drug is a product that compares </li></ul><ul><li>to the pioneer, or reference, drug product (usually a branded </li></ul><ul><li>drug) in dosage form, route of administration, strength, quality, </li></ul><ul><li>safety, and performance characteristics. </li></ul><ul><li>Filiz hinchal,in 2009, An introduction to safety issues in </li></ul><ul><li>biosimilars/follow-on biopharmaceuticals </li></ul><ul><li>Biopharmaceuticals are emerging global healthcare tools, which </li></ul><ul><li>promise to provide effective treatment of many serious and life- </li></ul><ul><li>threatening illnesses with their high specificity and activity; they </li></ul><ul><li>are considered the future of drug therapy. </li></ul><ul><li>Holmes CB , 2010, Use of generic antiretroviral agents and </li></ul><ul><li>cost savings in PEPFAR treatment programmes. </li></ul><ul><li>One of the biggest hurdles to the rapid scale-up of antiretroviral </li></ul><ul><li>therapy in the developing world was the price of antiretroviral </li></ul><ul><li>drugs (ARVs). </li></ul>
  9. 9. <ul><li>Chow sc , 2010, Statistical assessment of biosimilar </li></ul><ul><li>products </li></ul><ul><li>Biological products or medicines are therapeutic agents that are </li></ul><ul><li>produced using a living system or organism. Access to these life- </li></ul><ul><li>saving biological products is limited because of their expensive </li></ul><ul><li>costs. </li></ul><ul><li>Howland RH, 2010, Evaluating the bioavailability and </li></ul><ul><li>bioequivalence of generic medications </li></ul><ul><li>The U.S. Food and Drug Administration (FDA) is permitted to </li></ul><ul><li>approve generic versions of brand-name medications without </li></ul><ul><li>necessarily requiring that research be conducted to prove them </li></ul><ul><li>safe and effective, provided that a number of criteria are met. </li></ul><ul><li>The most important criterion is bioequivalence. Bioavailability </li></ul><ul><li>refers to the rate and extent to which the active ingredient is </li></ul><ul><li>absorbed from a drug product. Bioequivalence means that there </li></ul><ul><li>is an equivalent rate and extent of absorption of the same active </li></ul><ul><li>ingredient from two or more drug products. </li></ul>
  10. 10. REGULATORY GUIDELINES FOR DOSSIER SUBMISSION IN USA
  11. 11. Dossier is submitted in CTD format. <ul><li>CTD format </li></ul><ul><li>Aim </li></ul><ul><li>To harmonize the structure and format of registration documentation. </li></ul><ul><li>Benefits </li></ul><ul><li>Complete, well-organized submissions </li></ul><ul><li>Facilitates electronic submissions </li></ul><ul><li>Easier analysis across applications etc. </li></ul>
  12. 12. Regional Admin Information Module-1 Nonclinical overview Clinical overview Clinical Summary Quality overall summary Quality Module-3 Nonclinical Studies Reports Module-4 Clinical Study Reports Module-5 The CTD Module-2 Not Part of CTD
  13. 13. <ul><li>The CTD is organized into five modules: </li></ul><ul><ul><li>Module 1 is region specific. </li></ul></ul><ul><ul><li>Modules 2, 3, 4, and 5 are intended to be common for all regions. </li></ul></ul><ul><li>Module 1. Administrative Information </li></ul><ul><ul><li>Should contain documents specific to each region; </li></ul></ul><ul><ul><li>e.g. application forms or the proposed label for use in the region. </li></ul></ul>
  14. 14. 1.1 Table of Contents of the Submission 1.2 Documents Specific to Each Region (for example, application forms,prescribing information,)
  15. 15. Module 2. CTD Summaries Begin with a general introduction to the pharmaceutical (its pharmacological class, mode of action, proposed clinical use. It contain 7 sections in the following order: 2.1 Common Technical Document Table of Contents (Modules 2-5) 2.2 CTD Introduction 2.3 Quality Overall Summary
  16. 16. 2.4 Non-clinical Overview 2.5 Clinical Overview 2.6 Non-clinical Written and Tabulated Summaries 2.7 Clinical Summary Module 3. Quality 3.1 Table of Contents of Module 3 3.2 Body of Data [Drug Substance, Drug Product & Regional information] 3.3 Literature References
  17. 17. Module 5. Clinical Study Reports 5.1 Table of Contents of Module 5 5.2 Tabular Listing of All Clinical Studies 5.3 Clinical Study Reports (BA/BE) 5.4 Literature References
  18. 18. REGULATORY GUIDELINES FOR DOSSIER SUBMISSION IN Europe
  19. 19. <ul><li>Pharmaceutical companies of EU are use three approval procedures to market their pharmaceuticals </li></ul><ul><li>A centralized or </li></ul><ul><li>A decentralized or </li></ul><ul><li>Mutual recognition </li></ul><ul><li>Centralized procedure- </li></ul><ul><li>Allows a pharmaceutical company to market its </li></ul><ul><li>pharmaceutical product in all 25 member states </li></ul><ul><li>Without having to obtain separate approvals from </li></ul><ul><li>each member state </li></ul>
  20. 20. Draft decision of the commission
  21. 21. <ul><li>Decentralized procedure- </li></ul><ul><li>An applicant can go directly to a national </li></ul><ul><li>marketing authority to obtain permission to </li></ul><ul><li>market its product in that member state and </li></ul><ul><li>Then seek to have other member states </li></ul><ul><li>accept the marketing approval of the first </li></ul><ul><li>member state. </li></ul>
  22. 23. Mutual recognition procedure (MRP)- Used in order to obtain marketing authorizations in several Member States where the medicinal product in question has received a marketing authorization in at least one Member State at the time of application.
  23. 24. DIFFERENCE b/w eu & fda
  24. 25. <ul><li>EU </li></ul><ul><li>Multiple agencies </li></ul><ul><ul><li>European Medicines Evaluation Agency </li></ul></ul><ul><ul><li>(EMEA) – administrative organization </li></ul></ul><ul><ul><li>Committee for Medicinal Products for </li></ul></ul><ul><ul><li>Human Use (CHMP) of the EMEA – scientific </li></ul></ul><ul><ul><li>input </li></ul></ul><ul><ul><li>National Health Agencies </li></ul></ul><ul><li>FDA </li></ul><ul><li>One agency </li></ul>
  25. 26. <ul><li>EU </li></ul><ul><li>Multiple registration procedures </li></ul><ul><ul><li>Centralized </li></ul></ul><ul><ul><ul><li>European Community </li></ul></ul></ul><ul><ul><li>Decentralized/Mutual Recognition </li></ul></ul><ul><ul><ul><li>At least 2 Member States </li></ul></ul></ul><ul><ul><li>National </li></ul></ul><ul><ul><ul><li>1 Member State </li></ul></ul></ul><ul><li>FDA </li></ul><ul><li>One registration procedure </li></ul>
  26. 27. EU TSE /BSE study data is required Braille code is required on labeling FDA TSE /BSE study data is not required Braille code is not required on labeling
  27. 28. REGULATORY GUIDELINES FOR DOSSIER SUBMISSION IN INDIA
  28. 29. <ul><li>Drug & Cosmetic Act 1940 & Rules 1945 </li></ul><ul><li>Regulates the import, manufacture, </li></ul><ul><li>distribution & sale of drugs & </li></ul><ul><li>cosmetics. </li></ul><ul><li>Schedule Y </li></ul><ul><li>Provides guidelines & requirements for </li></ul><ul><li>clinical trials </li></ul>
  29. 30. <ul><li>CDSCO </li></ul><ul><li>A licensing authority for approval of new drug </li></ul><ul><li>proposed to be imported </li></ul><ul><li>Head office located in New Delhi & functioning </li></ul><ul><li>under the control of directorate general of </li></ul><ul><li>Health services, MHFW, Govt of India. </li></ul><ul><li>DCGI </li></ul><ul><li>Responsible for approval of new drug & </li></ul><ul><li>Clinical trials to be conducted in India </li></ul><ul><li>Appointed by Central Govt of India </li></ul>
  30. 32. COMPARATIVE STUDY OF DOSSIER SUBMISSION PROCESS OF DRUG PRODUCT IN USA, EU, India
  31. 33. S.No. Requirements USA EU India A. ADMINISTRATIVE 1. Application ANDA MAA MAA 2. Debarment Certification Required NA NA 3 No. of copies 3 1 1 4 Approval time line 18 Month 12 Month 12 Month 5 Fees No Fees 10-20 Lakh 50,000 6 Presentation eCTD & Paper eCTD Paper B. FINISHED PRODUCT CONTROL 1. Justification ICHQ6A ICHQ6A ICHQ6A
  32. 34. S.No. Requirement USA EU India 2. Assay 90-100% 95-105% 90-110% 3. Disintegration Not required Required Required 4. Color Identification Not required Required Required 5. Water content Required Not Required Required C. MANUFACTURING & CONTROL 1. No. of batches 01 03 1 2. Packaging A min of 1,00,000 Units Not Required - 3. Process validation Not required at the time of submission Required Required 4. Batch size Min of 1,00,000 Units Min of 1,00,000 Units Not Specified
  33. 35. S.No. Requirement USA EU India D. STABILITY 1. No. of batches 01 02 01 2. Condition 25/60: 40/75 25/60: 40/75 30/35; 30/70 3. Date & Time of submission 3 Month Accelerate & 3 Month Long term 6 Month Accelerate & 6 Month Long term 6 Month accelerated & 3 Month Long term 4. Container orientation Inverted & Upright Do not address Do not address 5. Clause 21CFR Part 210 & 211 Volume4, EU guidelines for medicinal product ICHQ1F 6. QP Certification Not Required Required Required
  34. 36. S.No. Requirement USA EU India E. BIOEQUIVALENCE 1 CRO Audited by FDA Audited by MHRA CDSCO 2. Reserve sample 5 Times the sample required for analysis No such requirement - 3. Fasted/Fed Must be as per OGD recommendation NO such requirement As CDSCO recommendation 4. Retention of samples 5 Year from the date of filing the application No such requirement but usually followed 3 years from date of filing the application
  35. 37. <ul><li>SUMMARY </li></ul><ul><li>In this presentation we did individually study about the rule & regulations which are followed for drug approval process in USA, Europe & India. </li></ul><ul><li>Data in the dossier gives the answer of following questions: </li></ul><ul><li>  </li></ul><ul><li>What is the product? </li></ul><ul><li>Is the quality presented acceptable on grounds of </li></ul><ul><li>safety and efficacy? </li></ul><ul><li>Is the quality presented reproducible? </li></ul><ul><li>How long can the quality be maintained? </li></ul><ul><li>Quality must ensure consistency of safety and </li></ul><ul><li>efficacy during the shelf life of all batches </li></ul><ul><li>produced. </li></ul>
  36. 38. And in last we did the comparative study. This comparative study of dossier compilation given a brief idea about the difference in regulatory requirements for drug approval process among USA, EU & India.
  37. 39. <ul><li>Conclusion   </li></ul><ul><li>Significantly reduces the time and resources </li></ul><ul><li>needed to compile applications for registration </li></ul><ul><li>of human pharmaceuticals </li></ul><ul><li>Eases the preparation of electronic submissions </li></ul><ul><li>Facilitates regulatory reviews and </li></ul><ul><li>communication with the applicant by a standard </li></ul><ul><li>document of common elements </li></ul><ul><li>Simplifies exchange of regulatory information </li></ul><ul><li>between Regulatory Authorities </li></ul><ul><li>  </li></ul>
  38. 40. <ul><li>Provide for a scientifically sound means of </li></ul><ul><li>establishing the quality, safety and efficacy of </li></ul><ul><li>therapeutic products </li></ul><ul><li>Improve the transparency, predictability and </li></ul><ul><li>efficiency of the regulatory process </li></ul><ul><li>Contribute to reducing unnecessary regulatory </li></ul><ul><li>burden and promoting industry compliance </li></ul><ul><li>Promote bilateral and multilateral regulatory </li></ul><ul><li>communication and cooperation –common </li></ul><ul><li>regulatory platform </li></ul><ul><li>Level playing field good for export market </li></ul><ul><li>  </li></ul>
  39. 41. <ul><li>Generic drugs, website- www.wikipedia.org/wiki/generic-drug. </li></ul><ul><li>2. CTD Guidelines map (ICH,EMEA AND FDA), website </li></ul><ul><li>www.reg- info.com/ctd-guidelines </li></ul><ul><li>3. Drug price compitition & patent term restoration act of 1984, </li></ul><ul><li>website-http://www.cptech.org/ip/health/generic/hw.html </li></ul><ul><li>4.180-day generic exclusivity, website- </li></ul><ul><li>ww.fda.gov/downloads/Drugs/.../Guidances/ucm079342.pdf </li></ul><ul><li>  </li></ul><ul><li>5. Bioequivalence and Generic Medicines Introduction, website- </li></ul><ul><li>www.egagenerics.com/doc/zanen-biogenerics.pdf </li></ul><ul><li>6. Introduction - European Agency for the Evaluation of </li></ul><ul><li>Medicinal products, website- www.emea.europa.eu/docs/en_GB/...library/.../WC500074880.pdf </li></ul>REFERENCE
  40. 42. 7. EMEA and Overview of the Centralised Procedure, website- www.who.int/entity/vaccine_research/diseases/influenza/Celis.pdf 8. Matin s.lipsky,lisa k. sharp, The drug approval process, Jabfp, sep-oct 2001,vol 14(5) 9. Welage LS kinking dm,ascione FJ, gaither CA. Understanding scientific issues embedded in the generic drug approval process,2001.feb- may04(5);114-30. 10. Lionberger RA., FDA critical path- initiatives, Opportunities for generic drug development.AAPS J.2008, 10(1): 103-9, Epub2008 feb20. 11. Peters JR,hixon DR, conner DP, davit BM, catterson DM, parise CM generic drugs-safe, effective and affordable dermotol ther.2009 may-jun,22(3);229-40 12. Jaime R hornecker, Generic drugs: history, approval process and current challenges , US pharm2009,34(6),26-30
  41. 43. 13. Filiz hinchal, An introduction to safety issues in biosimilars/follow-on biopharmaceuticals, Jmed cbr 7,1 sept. 2009 14. Holmes CB, coggin W,jamiesn D mihm H,rrancn R,savio P,Hope M,ryan C,moloney-kitts M,goosby EP, dybul M, use of generic antiretroviral agents and cost savings in PEPFAR treatment programmes. JAMA 2010 jul21,304(3) 313-20. 15. Chow sc lio.jp, Statistical assessment of biosimilar products. J.bio pharm stat2010 Jan, 20(1); 10-30. 16. Howland RH, Evaluating the bioavailability and bioequivalence of generic medications, J. psychosocial nursing and mental health serv.2010jan, 48(1) 17. Submitting Marketing Applications According to the ICH-CTD Format - General Considerations, website- http://www.fda.gov/RegulatoryInformation/Guidances/ucm129703.htm
  42. 44. 18.Revision History Module 1 Administrative informationwebsite- www.fda.gov/downloads/Drugs/.../UCM163175.pdf 19.FDA Debarment List (Drug Product Applications), website- www.fda.gov/ICECI/.../FDADebarmentList/default.htm 20. Guidance for Industry - FDA, www.fda.gov/.../Drugs/.../FormsSubmissionRequirements/ElectronicSubmissions/UM163188.pdf 21. ICH Guideline: The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - M4Q; Quality Overall Summary of Module 2, Module 3: Quality,:http://www.ich.org
  43. 45. THANK YOU

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