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Compliance Processes for Life Science Products in Brazil, Russia, India, China markets - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations: 2-day In-person Seminar

By:
Robert J. Russell, President of RJR Consulting, Inc
Location:-
Miami, FL
| Wednesday, September 17, 2014 | Thursday, September 18, 2014

Course Description:

This seminar will help you understand the regulatory, quality and import / export requirements for Life Science Products in emerging markets - Brazil, Russia, India and China.

Improved alignment to global standards was an important step forward toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies. Healthcare Authorities and regulatory systems have now made their requirements and procedures more transparent to industry partners. Clinical Trials can be conducted at a fraction of the expense.

Structured healthcare systems and insurance coverage is now more prevalent among these emerging nation populations and predictions for growth of Rx and OTC products is impressive in these relatively untapped markets.

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Brazil, Russia, India and China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies. Content will also include descriptions of the methods by which regulators review filings and registrations and what is expected in the authorization and dossier maintenance of licensed products throughout their life.

Understanding cultural norms, establishing relationships and protecting your intellectual property will also be discussed and these will need to be integrated into your company training and corporate business strategies.



Learning Objectives:

This course is designed to provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of Life Science Products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in these emerging markets. It will provide training on:

  • The Nation's Regulatory Structure.
  • Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
  • How to begin your company's involvement in each country (Brazil, Russia, India, China): local licenses, in-country personnel required and facilities required or contracted
  • Clinical Trials: When are Clinical Trials needed? When are they not? Healthcare Authority requirements, the Application Process, Ethics Committee approval, CRO Selection and Start-up
  • The current key regulations effecting product development and your company's product pipeline
  • Product Licensing / or Registration; Licensing differences across Product Types
  • Pricing establishment
  • Healthcare Insurance systems and reimbursement
  • Understanding the local concerns and specific challenges in working with each country's Regulatory Authority
  • Understanding the Local Culture: Realistic expectations, timing on reviews, effective strategies for adding each market to your company's global market presence
  • Information necessary for effective dossier preparation; or how does one take an already approved dossier and turn it into an acceptable submission package
  • Strategies for streamlining the registration application process for faster approval
  • Maintenance on Authorized Products
  • License Renewals
  • Import / export; Licenses and Supply Chain considerations


Who will Benefit:

This course will be beneficial to the following personnel whose responsibilities require knowledge of these Emerging Markets' regulatory requirements for Life Science products:

  • Regulatory Affairs
  • Quality
  • Clinical
  • Manufacturing
  • Supply Chain
  • Import / Export
  • Global Business Development
  • General Management
  • Administrative Staff


Topic Back Ground:

More than ever, the World has become one integrated market for conducting Global Clinical Research and for expanding the market for pharmaceuticals, biologics, medical devices and combination products. The time and expense of bringing new products to market continue to challenge budgets and existing balance sheets. While it is necessary to continue to have a robust pipeline of new patented products, global producers have been evaluating how best to begin participating in the emerging markets of Brazil, Russia, India and China. Manufacturers are looking to tap into the huge population areas of the World and bring innovative products to these patient populations. Taking products which already have existing country licenses and expanding these licenses into BRIC nations is proving to be an effective strategy for those who have begun.

The BRIC nations, as they are known (Brazil, Russia, India and China) have been improving the sophistication of their regulatory regime governing the food and Life Science products industry in recent years. This has included amending GMP ,GLP, GCP, GSP and other regulations allowing their country policies to further align with international standards of practice. This better alignment will assist the growth in these markets for new and already licensed products. For manufacturers and distributors of Life Science Products in these emerging markets, it is important to pay close attention to the pace at which their Healthcare Agencies implement these changes. Manufacturers and distributors must in turn add this knowledge and adjust their standard operating procedures when necessary to ensure compliance with the evolving regimes.

This course will be beneficial to Regulatory, Quality, Clinical, Manufacturing, Supply Chain, Global Business Development and General Management personnel whose responsibilities require knowledge of these Emerging Market’s regulatory, quality and import / export requirements. Additionally, administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements will also find this training highly relevant. Global business development and general management requiring an understanding of how regulations and compliance issues must be followed in finding a local distributor / partner, setting up a company office or establishing local or contract manufacturing facility will profit from attending.





Areas Covered/Agenda:

DAY 1 (8:30 AM – 3:30 PM)

DAY 2 (8:30 AM – 3:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

    BRAZIL
  1. Country Profile / Healthcare System.
  2. Key Country Information.
  3. Strategic Considerations: Why Brazil? / Latin America Structure / Hub Locations.
  4. Governmental & Regulatory Authorities / Agencies / Structure.
  5. Company Establishment; Licenses & Key Personnel
  6. Establishing In-Country Partners / Distributors.
  7. In-Country Operational Considerations; Licenses, personnel, operations.
  8. Requirements to Conduct Clinical trials / Approvals / GCP.
  9. Licensing Products.
    • Innovative Drugs
    • Generics / Similars
    • Orphan Drugs
    • Biologics / Vaccines
    • Medical Devices
    • Combination Products
  10. Variations and Amendments to Licenses.
  11. GMP and Inspections.
  12. Packaging and Labeling.
  13. Price Establishment.
  14. Insurance Reimbursement.
  15. Import / Export / Customs Clearance.
  16. Taxes / Duties.
  17. Advertising & Promotion Allowances or Restrictions.
  18. Vigilance Reporting / Post-Marketing Requirements.
  19. Patents & Trademarks; Protecting Your Intellectual Property.
  20. Local Customs / Cultural Issues / Establishing Business Relationships.
  21. Working with Local Agencies / Authorities.
  22. Conclusions.

  23. CHINA
  24. Country Profile / Healthcare System.
  25. Key Country Information.
  26. Strategic Considerations: Why China? / Asia-Pacific Structure / Hub Locations.
  27. Governmental & Regulatory Authorities / Agencies / Structure.
  28. Company Establishment; Licenses & Key Personnel
  29. Establishing In-Country Partners / Distributors.
  30. In-Country Operational Considerations; Licenses, personnel, operations.
  31. Requirements to Conduct Clinical trials / Approvals / GCP.
  32. Licensing Products.
    • Innovative Drugs
    • Generics / Similars
    • Orphan Drugs
    • Biologics / Vaccines
    • Medical Devices
    • Combination Products
  33. Variations and Amendments to Licenses.
  34. GMP and Inspections.
  35. Packaging and Labeling requirements.
  36. Price Establishment.
  37. Insurance Reimbursement.
  38. Import / Export / Customs Clearance.
  39. Taxes / Duties.
  40. Advertising & Promotion Allowances or Restrictions.
  41. Vigilance Reporting / Post-Marketing Requirements.
  42. Patents & Trademarks; Protecting Your Intellectual Property.
  43. Local Customs / Cultural Issues / Establishing Business Relationships.
  44. Working with Local Agencies / Authorities.
  45. Conclusions.
    INDIA
  1. Country Profile / Healthcare System.
  2. Key Country Information.
  3. Strategic Considerations: Why India? / Asia-Pacific Structure / Hub Locations.
  4. Governmental & Regulatory Authorities / Agencies / Structure.
  5. Company Establishment; Licenses & Key Personnel
  6. Establishing In-Country Partners / Distributors.
  7. In-Country Operational Considerations; Licenses, personnel, operations.
  8. Requirements to Conduct Clinical trials / Approvals / GCP.
  9. Licensing Products.
    • Innovative Drugs
    • Generics / Similars
    • Orphan Drugs
    • Biologics / Vaccines
    • Medical Devices
    • Combination Products
  10. Variations and Amendments to Licenses.
  11. GMP and Inspections.
  12. Packaging and Labeling.
  13. Price Establishment.
  14. Insurance Reimbursement.
  15. Import / Export / Customs Clearance.
  16. Taxes / Duties.
  17. Advertising & Promotion Allowances or Restrictions.
  18. Vigilance Reporting / Post-Marketing Requirements.
  19. Patents & Trademarks; Protecting Your Intellectual Property.
  20. Local Customs / Cultural Issues / Establishing Business Relationships.
  21. Working with Local Agencies / Authorities.
  22. Conclusions.

  23. RUSSIA
  24. Country Profile / Healthcare System.
  25. Key Country Information.
  26. Strategic Considerations: Why Russia? / Eastern European Structure / Hub Locations.
  27. Governmental & Regulatory Authorities / Agencies / Structure.
  28. Company Establishment; Licenses & Key Personnel
  29. Establishing In-Country Partners / Distributors.
  30. In-Country Operational Considerations; Licenses, personnel, operations.
  31. Requirements to Conduct Clinical trials / Approvals / GCP.
  32. Licensing Products.
    • Innovative Drugs
    • Generics / Similars
    • Orphan Drugs
    • Biologics / Vaccines
    • Medical Devices
    • Combination Products
  33. Variations and Amendments to Licenses.
  34. GMP and Inspections.
  35. Packaging and Labeling requirements.
  36. Price Establishment.
  37. Insurance Reimbursement.
  38. Import / Export / Customs Clearance.
  39. Taxes / Duties.
  40. Advertising & Promotion Allowances or Restrictions.
  41. Vigilance Reporting / Post-Marketing Requirements.
  42. Patents & Trademarks; Protecting Your Intellectual Property.
  43. Local Customs / Cultural Issues / Establishing Business Relationships.
  44. Working with Local Agencies / Authorities.
  45. Conclusions.




Meet Your Instructor

Robert J. Russell
President of RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.





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Testimonials

What past attendees say

Presenter was very knowledgeable. A good number of participants were there and it was a highly interactive seminar.
- Sr. Dir. Legal Counsel, Boston Scientific

This seminar was very informative especially the topics related to Brazil. Speaker was very knowledgeable on this topic.
- Project Manager, Genentech

It was a great seminar and I found it extremely informative. Interaction among participants was really great.
- Vice President, Quality, Optimer Pharmaceuticals, Inc

Seminar was quite interesting especially in terms of good networking and sharing personal experiences.
- Regulatory Affairs, Bio-Rad Laboratories

This seminar was really useful and it did provide some good insight on drugs and biologics compliance process for BRIC.
- Specialist, Quality Assurance, International Quality, Amgen Inc

This seminar was good and it was good to get an understanding of medical device registration because I work in Regulatory Affairs.
- Reg. Affairs Associate, Bard Peripheral Vascular

It did provide very useful information about Russia and China Life Science products compliance processes.
- Reg. Affairs Associate, Bard Peripheral Vascular

Presenter was very knowledgeable. Topic Biologics import to these countries were really useful as this is related to my current job profile.
- QA, Baxter

Instructor was really good and he had given good examples related to the subject. Classroom participation was great. Cultural issues discussed were extremely helpful because these are the unwritten rules that have significant impact for product approval.
- Senior Quality Manager





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