Latin america


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Latin america

  1. 1. Live Webinar on : Latin America: Regulatory Compliance Requirements for Life ScienceProducts (Focus: Brazil, Mexico, Argentina) Tuesday, March 20, 2012duration : 01:00 to 02:30 PM EST Description Why Should You Attend: This course specifically focuses on the overall regulatoryGet 15 % Discount as an early bird compliance requirements and procedures forregistration. Use Promo Key : Pharmaceuticals, Medical Devices, Biologics and CGO15 Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil andWho 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 inthe Latin American regulatory Latin America. Content will include descriptions of theenvironment 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 maintenanceensuring compliance with regulatory of licensed products.filings and overall regulatorycompliance 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. 2. • Global Business Developmentpersonnel Agenda: (All time in EST)• Any sales or general managementemployee requiring an understanding 1:00 – 2:15 pm Course Deliveryof how regulations and complianceissues 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 Americas Regulatory Structure for the Life Scienceattendance (To be arranged in a Product IndustriesConference 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. 3. • Marketing Authorization Processes - Filings &Registrations.o Drug vs. Medical Device vs. Biologic vs. CombinationProduct.• 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. 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 Dos and Donts of Regulatory Involvement.• How to Use Regulations / Regulatory Contacts to YourAdvantage.o Check-in Procedure.o Agency Interactions.o Business Impact Within and Outside Latin America.o Professionalism in Regulatory Lobbying.• Resources / Helpful WebsitesAbout Speaker:Robert J. Russell, is President and CEO of RJRConsulting, Inc, a leading Global Regulatory Consultingfirm focusing on assisting the Life Science Industry.Prior to founding the firm in 2000, Mr. Russell had
  5. 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 Chemistry Compliance2go | Phone : 877.782.4696 | Fax : 281-971-0286 Email :