2. Key Points (1) Definitions: Bureaucracy. Regulatory Affairs. Quality: Historic. Quality Wave. Benefits.

3. Key Points (2) Regulatory Affairs: Historic. American and European Systems. LATAM: Products and Services. The regulatory affairs system as a non-tariff barrier. The Regulatory Affairs’ maintenance cost. When the RA meets the Bureaucrassaur! The Regulatory Affairs Professional: this distinguished unknown... When the RA meets the Bureaucrassaur! The Regulatory Affairs Professional: this distinguished unknown... Conclusions. Questions & Aswers.

4. Definitions Do you know the difference between Bureaucracy and Regulatory Affairs?

5. Definitions Bureaucracy: 1.Administration of the public thing by public employee subject to hierarchy, rigid rules and inflexible routine; 2.Complication or slowing in the development of the public services. Regulatory Affairs: Group of laws, norms and technical regulations that determine the participation of buyers and vendors in a certain field of the regulated economic activity.

6. Let’s talk a little bit about Quality?

7. Historic of Quality Evolution World Chronology 1900 Inspection made by the employee / supervisor 1920 Quality Control as a specialized function 1940 Statistical Control of the process 1960 Total Quality 1980 Systems of Quality Assurance 2000 Quality Systems Management

8. Still talking about Quality Features: Defined systems. Measurable. Standardization. Performance Indicators. Benefits: Costs reduction. Control of the measurable parameters. Process monitoring. Domain of the process (reliability). Routine optimization. Objective improvement of the goods.

9. Regulatory Affairs Did you receive the unexpected visit of the Inspector???

10. Regulatory Affairs Hiding is not an option...

11. Regulatory Affairs Insulting the inspector will just make things worse...

12. Regulatory Affairs How about solving the problems and try to understand the Regulatory Affairs’ rules??? After all your business continues to be extremely attractive!!!

13. Historic XVIII and XIX centuries – Harbor Police (Brazil) I and II World War – re-directed to therapeutic. 1976 – Health Products Legislation Started 1999 – Establishment of the First Federal Agency Fully Dedicated to Regulatory Affairs (Brazil)

14. Mission / Values / Vision Of The Latam Regulatory Affairs System From ANVISA (that is followed by other countries) Mission "To protect and promote health, ensuring the hygiene and safety of products and services and taking part in developing access to it." Values Transparency Knowledge (as a springboard for action) Cooperation. Vision To be an agent for transformation of the decentralized regulatory system, within a network, holding a distinct position, legitimized by the population, as regulator and promoter of social well-being.

15. CONTROL Basic Actuation: Manufacturers and Importers of: Pharmaceuticals; Cosmetics; Sanitizers; Food; Medical Products (equipments, consumables and disposables). Health services (hospitals and clinics). Harbors, airports and frontiers.

16. Summarizing: LATAM Regulatory Affairs Authorities determines the rules of the game from the manufacturing, importing and distributing point of view as well as health services. The system is mostly reactive (but not exclusively) answering to past events.

17. Are you following???

18. Summarizing the Scenario… Products and services controlled by LATAM Regulatory Affairs authorities have rules clearly determined. To survive and gain some competitive advantage you must understand the LATAM Regulatory Affairs System. Do not try to play games because LATAM Regulatory Affairs authorities are monitoring the market (hey, I am talking to you!!!) TRY TO GUESS WHO’S YOUR COMPANY…

19. European and American System Europe : System created after the 2nd World War to integrate all States: planning (pro-active system). Products approved can be freely sold in all EU territory. Each Nation is free and independent to adopt the directives at its own time and convenience. United States of America: Reactive system created to inspect all companies and products. Separations of the state and federal authorities.. Pressure. Federal product registration is required.

20. European and American System Common points of the two systems : Facilities : Quality standards based on the activities developed. Products: Classified according to the risk. Regulated by class of products. Product use as indicated by the manufacturer but the user can change it under his/her own responsibility. Techno and Pharmaco Vigilance. Control of the Clinical Evaluation Protocols under the express agreement of the volunteers.

21. Latin America Countries Operation : like FDA: Central power. Decentralized action. Requires: Registration of the manufacturers and importers. Registration of Products. Documents required : like EU’s Master File.

22. Company’s Working Permit Approval Company Establishment: - Social Contract; - Tax ID Card - Facilities; - Legal and Technical Responsible. Preparation and Submission of the 1:100 Print + Lay Out for local Approval. (60 - 90 days) Preparation and Submission for the Local Working Permit. (120 days) Preparation and Submission for the Federal Working Permit (90 days) Extra Zone Inspection

23. Product Registration Collection of the Needed Documents Critical Analysis of the Documentation Assembling of the Technical Dossier According to the LATAM Requirements Fees Payment and Collection of the Needed Signatures Submission of the Technical Dossier Technical Analysis by LATAM Staff Product Approval (Publication in the Federal Official Gazette) Request for Additional Information Preparation and Submission of the Requested Information

24. Basic List of Needed Documents for Products Registration COMPANY’S WORKING PERMIT FREE SALES CERTIFICATE* (WHEN APLICABLE) LETTER OF DISTRIBUTION* (WHEN APLICABLE) CERTIFICATE OF CONFORMITY GMP CERTIFICATE INSTRUCTIONS OF USE / INSERTS SERVICE / INSTALATION MANUAL LABELING PACKING COMPOSITION / QUALI-QUANTI FORMULA BASIC MANUFACTURING FLOWCHART CERTIFICATION OR LOCAL TESTS MAY BE REQUIRED DEPENDING ON THE PRODUCT VALIDATION OF STERILIZATION PROTOCOL (WHEN APPLICABLE) PROOFS OF SAFETY AND EFFECTIVENESS (*) Consularization required in the closest embassy/consulate of the countrie where the product will be registered.

25. Attention now! Let’s talk about the Non Tariff Barriers.

26. In front of the Regulatory Affairs scenario you can behave like this...

27. Or like that!

28. Non Tariff Barriers In the whole World NOW! Commercial agreements being signed among countries of a same group (Mercosur, Alca, CEE, Nafta, etc.). Commercial agreements being signed among countries of different groups (Brazil and China, Brazil and México, etc.). The agreements define the commercial conditions: Tariffs and Quotes of Purchasing.

29. What kind of protection is left then? ** Regulatory Barriers ** : The countries have autonomy to define the rules of the game regarding quality, products specification, ways to register a product, documents and tests required, etc. Non Tariff Barriers

30. Trying to Manufacture, Export or Import without being in conformity with the Regulatory system???

31. Regulatory System X Bureaucrassaur.

32. Regulatory System X Bureaucrassaur In Brazil: 152 days: time to legally establish a company in Brazil. Number of Needed Procedures: 17 Up to10 years: time to close a company in Brazil.

33. Local Working Permit:120 days up to 1 year. Federal Working Permit: 30 up to 120 days. GMP Certificate by ANVISA: 1,5 up to 2,5 year. MD or IVD Registration: 2 up to 5 month. Approval of Clinical Evaluation Protocol: 6 month. High Cost for Regulatory Affairs Systems Maintenance. Regulatory System X Bureaucrassaur

34. Wait! You may not like what I am going to say but it is extremely important!

35. Do not follow your instinct to solve everything in “petit comitê”. Think BIG!

36. Regulatory Affairs System Advantages (Hawk X Turtle) Who Are You? HOW DOES YOUR COMPANY BEHAVE?

37. Some Advantages of Being in Conformity with Local Regulatory Affairs To be in conformity with the Local Legislation. As an answer to a market more and more conscious. Respect to the Consumer. Opening of new business opportunities. Advantage over non-conform competitors. Support to Import and Export process. Improves the Company’s image in the local market.

38. You did not like? Then, let’s see...

39. If you do not follow the local Regulatory Affairs Legislation. Arrest from 10 up to 15 years in jail. Company’s interdiction. No participation in public bids. No importation & exportation. Loss of company’s value (specially those in the stock market).

40. The regulatory issue has to be faced. There is no solution in trying the easy escape...

41. The Regulatory Affairs Professional.

42. RA Professional Profile (I) Need of various technical background (please do not sacrifice the assistant!). Experience in other carriers directed to technical areas. Experience in vital to the RA Professional. Management capabilities (technical and finance) and highly organized. Continuous education. The company MUST invest in the RA Professional.

43. RA Professional Profile(II) Ability to make market analysis, understand the legislation and new technologies and foreseen the future consequences that can affect the company’s business as well as present possible solutions. Support to the company’s team and for each member individually. Active participation in local associations, task forces and collaboration with Governmental Regulatory Affairs authorities.

44. RA Professional Profile - (Summary) Communication. Sympathy. Sociability. High interest in acquiring new information daily. Interest in continuous education. Knowledge of management, finance, project management and foreign languages. Deep technical knowledge of the products made / imported / sold by his (her) company.

45. If your company decides not to invest in Regulatory Affairs this will be the result...

46. But if they invest...

47. Conclusions (I) The CEO and ALL team has to monitor, scan and understand the scenario 100% of the time. It is a WAR operation! Keep you radar on all the time.

48. Conclusions (II) Risk Management must be the first thought in the mind of all team, specially for the Regulatory Affairs guys. To read and follow the legislation and technical norms daily is VITAL.

49. And Finally about LATAM It is a very interesting, growing and profitable market; Companies interested in selling in Latin America have to deeply know the local legislation; Anticipation is the “Magic” word when we think Latin America.

50. Thank You for your Attention and Patience!

52. Latini & Associados

53. Thank you!!! Thanks for each one of the Delegates (and their companies) for coming and participating in this learning session. More than a Seminar this was a precious trade of information; Thanks for Mrs.Andrea, CEO of Management Forum and all team for inviting us to come to this wonderful country and this marvelous historical land called Europe; Thank you all!!

54. You are the Champions !!!