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Harmonization and Opportunites (Nov 2015)

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An Outline on importance of Harmonization to deliver safe, efficacious and quality drugs to every body of globe

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Harmonization and Opportunites (Nov 2015)

  1. 1. Obaid Ali & Roohi B. Obaid Civil Services Officer at Drugs Regulatory Authority of Pakistan
  2. 2. Harmonization Creates Opportunities for Both Regulatory Professionals and Agencies in Developing Countries Roohi B. Obaid & Obaid Ali Civil Service Officer at Drug Regulatory Authority of Pakistan
  3. 3. Not the view of DRAP Current judgment of speaker No obligation on DRAP Regulatory experience It has nothing to do with any specific commercial product It is just a knowledge sharing exercise nothing more than that D I S C L A I M E R
  4. 4. Can anyone assess the Safety Efficacy & Quality of the drug by naked eye ?
  5. 5. Opening Message Visible, Sub-visible & invisible Challenges Harmonization, Globalization & Standardization Projects & Map of Opportunities Closing Message
  6. 6. If you want to go fast, go alone If you want to go far, go together
  7. 7. About Half a billion population died 4 Lac per year in Europe Recall the Retard Enemies and Sad Memories
  8. 8. Recall the Retard Enemies and Sad Memories Small pox Plague Meningitis Tuberculo sis Heart Attack Infections Psychiatry Diabetes
  9. 9. Current Issues & Challenges Hepatitis Ebola
  10. 10. Humans Their systems Their pain S I M I L A R
  11. 11. Humans Their systems Their pain S I M I L A R
  12. 12. Humans Their systems Their pain S I M I L A R
  13. 13. Do disease has a boundary? Quality Treatment ???
  14. 14. Every human deserves Quality Healthcare
  15. 15. Lets have a look at the back yard
  16. 16. Lets have a look at the back yard Toxic solvent DEG USA 1937 100s of deaths An antibiotic elixir
  17. 17. Lets have a look at the back yard
  18. 18. 2008 ? Lets have a look at the back yard Over sulfated chondroitin sulfate (OSCS)
  19. 19. Lets have a look at the back yard > 100 deaths PIC Tragedy Material Mix up
  20. 20. New Tools Approaches Standards E Q P S R E G U L A T O R Y S C I E N C E
  21. 21. Safety Efficacy Quality D R U G
  22. 22. Pre Marketing Review Inspection Post Marketing Evaluation Challenges
  23. 23. The Regulatory World is highly complex
  24. 24. Science of Regulation Innovation Safety ReasonableBalance
  25. 25. Science of Regulation Need justifies Outcome Benefit Risk
  26. 26. Science has one language & speaks with logic Lets enjoy benefits of science
  27. 27. Doctor Driver Technician Manufacturing facility Pharmacist All require a license to work/practice
  28. 28. Harmonization saves Resources
  29. 29. Harmoniz/sation Works ICH Japan EU ICH USA Observers: WHO & Canada
  30. 30. Balance is required between Fast Access Sovereign interest Western Medicine Economical Interest Innovation Safety Globalization Alternative Medicine Social Interest Stewardship
  31. 31. International Conference on Harmonization (ICH) Philosophy Identification and elimination of the need to duplicate studies to meet different regulatory requirements More efficient use of resources in the R&D process, as a consequence Quicker access for patients to safe and effective new medicines
  32. 32. Standardized Data Elements Controlled Vocabularies Common Format Outcomes
  33. 33. Speak same language Quality, accuracy & consistency Improve timeliness CTD/eCTD reduces delays and costs Outcomes
  34. 34. Global Regulatory Initiatives Joint Inspections Joint investigations Mutual Recognition Data sharing Memorandum of Understanding
  35. 35. APEC ASEAN GCC PANDRH SADC A Bridge from ICH to the world beyond Openness and Transparency Regional Harmonization Initiatives
  36. 36. International Compatibility Way to move forward Globalization Regulatory burden Innovation and Risk Capacity and Capability T I M E
  37. 37. Error
  38. 38. Models of Projects (Example) Brand Name Analysis
  39. 39. Sound and look alike…… Amaryl Reminyl Amaryl Reminyl Celebrex Cerebyx Celebrex Cerebyx Omacor Amicar Omacor Amicar
  40. 40. Intelence (Etravirine) Tablets Letters in Name INTELENCE Scripted may appear as Spoken may be interpreted as I e. L any vowel n v, r, s, m t f, r, x d e i, l any vowel l b, e, h c a, r S Look a like and sound alike letters
  41. 41. Relative Scale of Concerns N G B S E Q S E Q QES
  42. 42. Pre-Market Compliance Post-Market G B N Safety Efficacy Quality
  43. 43. Equal voice Consistency & Uniformity in decision Question based Review & Critical Thinking Organizational Approach
  44. 44. Learn, De-learn & Re-learn
  45. 45. Thanks
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An Outline on importance of Harmonization to deliver safe, efficacious and quality drugs to every body of globe


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