1. 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
Get 15 % Discount as an early bird
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.

2. • 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.

3. • 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.

4. • 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

5. 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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