Latin America

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					Live Webinar on : Latin America: Regulatory Compliance Requirements for Life Science
Products (Focus: Brazil, Mexico, Argentina) Tuesday, March 20, 2012

duration : 01:00 to 02:30 PM EST



                                         Description

                                         Why Should You Attend:

                                         This course specifically focuses on the overall regulatory
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                                         compliance requirements and procedures for
registration. Use Promo Key :
                                         Pharmaceuticals, Medical Devices, Biologics and
 CGO15
                                         Combination Products in Latin America. The primary
                                         countries covered will include: Argentina, Brazil and
Who will benefit                         Mexico. Other countries such asChile, Costa Rica,
                                         Dominican Republic, Panama, Peru and Venezuela will
                                         be discussed. The course will cover topics relating to
• Regulatory personnel whose             pre-clinical and clinical requirements, as well as,
responsibilities require knowledge of    addressing the structure of the regulatory agencies in
the Latin American regulatory            Latin America. Content will include descriptions of the
environment                              methods by which regulators in the corresponding
                                         agencies process filings and registrations and what is
• Administrative staff responsible for   expected in the authorization and dossier maintenance
ensuring compliance with regulatory      of licensed products.
filings and overall regulatory
compliance requirements                  The current regulatory climate in Latin America is
                                         discussed in detail and several examples will be
• QA / QC Personnel                      provided to illustrate effective compliance procedures
                                         and techniques. Common issues that have caused
                                         difficulties for Life Sciences firms in the region are
• Global Supply Chain personnel
                                         outlined. Course content will explain how Latin
                                         America interacts with and utilizes ICH standards and
• Clinical / Pharma & Device
                                         how they relate with other national regulatory agencies.
personnel
                                         Additionally, participants will learn how personnel can
                                         best address the conflicts, which arise and the best
• Manufacturing personnel
                                         course for resolution.
• Global Business Development
personnel
                                      Agenda: (All time in EST)
• Any sales or general management
employee requiring an understanding   1:00 – 2:15 pm Course Delivery
of how regulations and compliance
issues impact the organization        2:15 – 2:30 pm Q&A Session




                                      Areas Covered in the Session:

                                      • Glossary of Terms.
purchase formats
    $189 One Dial In - One            • Defining the Opportunity.
Attendee
                                      • Country Facts: Argentina, Brazil, Mexico.

     $249 One Dial In - Unlimited
                                      • Latin America's Regulatory Structure for the Life Science
attendance (To be arranged in a
                                      Product Industries
Conference room/Meeting room.
Note : Only One Dial In Allowed)
                                      • Mercosur - Southern Common Market.


    $289 On Demand (Recording         • Beginning Your Company Involvement in Latin America:
available within 48 hrs after the     Examples of Country Requirements.
completion of the webinar)
                                      • Registration / Required Country Licenses.

    $349 Get Training CD
                                      • Common Fees.




    More Trainings                    • Overview of the Rules Governing Medicinal Products &
                                      Medical Devices.


                                      o Select Examples of:Clinical Trials, GCP, GMP, Specials,
                                      Marketing Authorizations, Product Classifications, Scientific
                                      Advice, Generics Pricing, Patents, Labeling, SPC, Variations,
                                      Manufacturing Licenses, Renewals, Pharmacovigilance,
                                      Orphan Drugs.
• Marketing Authorization Processes - Filings &
Registrations.


o Drug vs. Medical Device vs. Biologic vs. Combination
Product.




• Drug Master File (DMF) Use in Latin America Registrations.


• Use of Expert Reports.




• Processing Variations on Licensed Products.


o Variations: Changes to Marketed Products.


o Types of Variations.


o Dossier Maintenance Expectations.


o Changes Concerning Manufacturing Aspects (Product &
Process).




• Labeling & Packaging Leaflet Requirements.


• Orphan Drugs / Rare Diseases.




• Comparing and Contrasting Latin American Procedures vs.
the U.S. FDA.


o Comparison of Processes.


o Agency Interactions.


o Accepted Practices.
• How and When to Influence the Regulatory Process.


o Accepted Country Practices.


o Effective Monitoring Activity.


o Association vs. Individual Company Involvement &
Intervention.




• The Regulatory Negotiation Process.


o Effective Approaches.


o The Do's and Don'ts of Regulatory Involvement.




• How to Use Regulations / Regulatory Contacts to Your
Advantage.


o Check-in Procedure.


o Agency Interactions.


o Business Impact Within and Outside Latin America.


o Professionalism in Regulatory Lobbying.




• Resources / Helpful Websites




About Speaker:

Robert J. Russell, is President and CEO of RJR
Consulting, Inc, a leading Global Regulatory Consulting
firm focusing on assisting the Life Science Industry.
Prior to founding the firm in 2000, Mr. Russell had
                                      over 27 years of experience in CMC, Global Business
                                      Development and Regulatory Compliance for
                                      pharmaceuticals, biologics, medical devices and
                                      combination products. The company has an office in
                                      Brussels, Belgium where they interact with the
                                      European Commission and the Competent Authorities
                                      across the EU. Country establishment, marketing
                                      authorizations, variations and license renewals are
                                      core competencies of the course director. Mr. Russell
                                      has received a B.S. and M.S.in Chemistry



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