Latin American Regulatory Conference (LARC) 2013

Overview

Based on the success of previous Latin American Regulatory Conferences (LARC) in 2009, 2011 and most recently, 2012, DIA will continue to present this dynamic symposium involving key stake holders to influence the advancement of regulatory convergence initiatives within Latin America.

Join Global Regulators, Industry and Academia to Engage in Strategic Discussion of the Current Regulatory Landscape, Future Research and Drug Development in Latin America.

Simultaneous Translation will be available in English and Spanish.

Featured Topics

Regulatory Landscape and Convergence Initiatives
Strengthening the Regulatory Framework
Efforts Underway by Convergence Initiatives
Reviews and Inspections
Ethics Committee Research in the Regions
Post Market Research Studies and Better Medicines to Influence
Efficacy and Effectiveness
Perspectives and Regulations of Pediatric Studies
Drug Safety, Marketing Surveillance and Quality Control Monitoring
Regulatory Concerns: Health Systems and Security of the Supply Chain
Current Regulations of Biologics and Biosimilars
Emerging Topics

Who Should Attend

Regulatory affairs
Clinical research and development
Clinical safety and pharmacovigilance
Clinical trial and project management
Drug development and discovery
Medical and scientific affairs
Preclinical development
Quality assurance
Research and development
Strategic sourcing/planning

Learning Objectives

Define the various initiatives related to global regulatory environment and their impact on the access of medicines and future R&D in Latin America
Discuss the progress of the PANDRH Convergence process and the current working groups

Hotel & Travel

TRAVEL AND HOTEL/VIAJE Y ACOMODACIONES
The most convenient airport is El Dorado International Airport (BOG) in Bogotá and attendees should make airline reservations as early as possible. El aeropuerto cercano más conveniente es el Aeropuerto Internacional El Dorado (BOG) en Bogotá. Se les exhorta a hacer sus planes de viaje lo más pronto posible. The Radisson Royal Bogotá Hotel is holding a block of rooms at the reduced rate below until April 9, 2013, for DIA attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.
El Hotel Radisson Royal Bogotá ha bloqueado un grupo de habitaciones y preparado un paquete especial para los asistentes de la Conferencia. Este precio sólo se le puede garantizar mientras haya disponibilidad o hasta antes del día 9 de abril del 2013.
Single $197+ Double $197+
****Residents of Colombia must pay taxes on this price/Foreigners exempt
Attendees must make their own hotel reservations.

Contact the Radisson Royal Bogota Hotel email: dcaicedo@radissonroyal.com; telephone at (57-1) 6578700 Ext. 50502 and mention the DIA event. Para hacer reservaciones favor de contactar a Diana Caicedo en el Hotel Radisson Royal Bogotá vía e maill dcaicedo@radissonroyal.com O por teléfono al (57-1) 6578700 Ext. 50502 y mencione el evento de la DIA. You can also book your hotel reservation using the following link/O haga sus reservaciones en línea utilizando el siguiente vínculo: www.Radisson.com/DIA Address/Direccion Radisson Royal Bogotá Hotel, Calle 113 # 7-65, Bogotá, Colombia

Contact Information

For further information:

Alejandro Bermudez-Del-Villar, MA/IBBD
Latin American and Global Development Coordinator
Alejandro.Bermudez@diahome.org

North America: Ms. Ellen Diegel
Event Planner
215.293.5810
Ellen.Diegel@diahome.org

Logistics in/Logistica en Bogotá: Sr. Hernando Salazar
Phone/telefono 57 1 4852911
DIA@eko-marketing.com

Program Committee

Previous Next

Program Committee 1-3 of 11

Justina A. Molzon, JD,MPharm

Associate Center Director for International Programs, CDER
FDA, United States

Mike D. Ward

Manager, International Programs Division
Health Canada, Canada

Sergio Guerrero, MD

Chair, DIA Advisory Council for Latin America
President/CEO, Accelerium Clinical Research, Mexico

Program Committee 4-6 of 11

Laura Gomes Castanheira

Manager of Research and Clinical Trials
COPEM/ANVISA, Brazil

Luis Eduardo Johnson Rojas, MD,MPH

Manager, Office of Clinical Trials and Bioethics
Instituto de Salud Publica de Chile (ISPCH), Chile

Lily Gordillo, MSc

Pharmacovigilance
Ministerio de Salud, Guatemala

Program Committee 7-9 of 11

Diana Valencia, MD

President
Asociación Para el Avance de La Investicación Clínica En Colombia (AVANZAR), Colombia

Yalil Bracho

Vice Presidente
AVANZAR, Colombia

Rivelino Flores

Medical Director
CANIFARMA, Mexico

Program Committee 10-11 of 11

Maria Guazzaroni Jacobs, PhD

Director, Quality and Regulatory Policy (QRP)
Pfizer Inc., United States

Arturo Rodriguez Jacob, MBA

Director
Infinite Clinical Research, Mexico

Agenda

Day 1 Wednesday, May 15, 2013

8:30AM - 9:00AM
Welcome and Opening Remarks

Session Chair(s):
- Mike D. Ward
  Manager, International Programs Division
  Health Canada, Canada
Speaker(s):
- Words on Pharmacovergence
  Justina A. Molzon, JD,MPharm
  Associate Center Director for International Programs, CDER
  FDA, United States
- Sergio Guerrero, MD
  Chair, DIA Advisory Council for Latin America
  President/CEO, Accelerium Clinical Research, Mexico
- Claudia Vaca, MD
  Advisor on Medicines
  Ministry of Health and Social Protection, Government of Columbia, Colombia
9:00AM - 9:30AM
Keynote
Speaker(s):
- Claudia Vaca, MD
  Advisor on Medicines
  Ministry of Health and Social Protection, Government of Columbia, Colombia
10:00AM - 11:50AM
Session 1: Updates on Regional and Global Convergence

Session Chair(s):
- Mike D. Ward
  Manager, International Programs Division
  Health Canada, Canada
This panel session will provide an update on the current harmonization / convergence activities to promote awareness: PAHO-Lead PANDRH, East African Community, Consortium of HC, SwissMedic, TGA and H.S.A., APEC Regulatory Harmonization Steering Committee, Generic Drugs Forum, among others.

Speaker(s):
- Regulatory Convergence
  Mike D. Ward
  Manager, International Programs Division
  Health Canada, Canada
- Columbian Perspective
  Claudia Vaca, MD
  Advisor on Medicines
  Ministry of Health and Social Protection, Government of Columbia, Colombia
- Chilean Perspective
  Elizabeth Armstrong González
  Head, Instituto de Salud Publica de Chile (ISPCH)
  Agencia Nacional de Medicamentos (ANAMED) , Chile
- PAHO Perspective
  Jose Daniel Peña Ruz
  Regional Advisor, Medicines and Health Technologies PAHO/WHO
  Pan American Health Organization (PAHO)/World Health Organization (WHO), Chile
- WHO Perspective ~ via video conference
  Lembit Rago
  Coordinator for Quality Assurance and Safety for Medicines
  World Health Organization (WHO), Switzerland
- Industry Perspective
  Diana Valencia, MD
  President
  Asociación Para el Avance de La Investicación Clínica En Colombia (AVANZAR), Colombia
11:50AM - 12:20PM
Question and Answer for Session 1
1:30PM - 2:30PM
Latin American Agencies Profiles by CIRS: Number of Reviewers, Inspectors, Timeliness, Predictability and Quality of a Full Review

Session Chair(s):
- Larry Liberti, MS,RPh,RAC
  Director
  Centre For Innovation In Regulatory Science (CIRS), United States
Latin American Agencies Profiles by CIRS: Number of Reviewers, Inspectors, Timeliness, Predictability and Quality of a Full Review
2:30PM - 3:30PM
Session 3: Case Study: Challenges faced by Regulators in the adoption of internationally recognized technical documents and standards
Speaker(s):
- Case Study: Challenges faced by Regulators in the Adoption of Internationally Recognized Technical Guidance Documents and Standards
  Jose Daniel Peña Ruz
  Regional Advisor, Medicines and Health Technologies PAHO/WHO
  Pan American Health Organization (PAHO)/World Health Organization (WHO), Chile
- Industry Perspective
  Claudia Marcella Prieto Quiroga
  Director, Regulatory Affairs
  Pfizer S.A.S., Colombia
3:45PM - 5:00PM
Session 4: Risk Based Approach to Inspections

Session Chair(s):
- Maria Guazzaroni Jacobs, PhD
  Director, Quality and Regulatory Policy (QRP)
  Pfizer Inc., United States
Session 4: Risk Based Approach to Inspections

Speaker(s):
- Risk Based Approach to Inspections
  Rafael Nevarez Nieves, MSc
  Assistant Regional Director, FDA Office Mexico
  FDA, Mexico
- Risk Based Approach to Inspections
  Laura Gomes Castanheira
  Manager of Research and Clinical Trials
  COPEM/ANVISA, Brazil
- Industry Perspective
  Mauricio Gantiva
  Quality Manager
  Pfizer Inc., Colombia
5:00PM - 6:00PM
Session 5: Integrity of the Supply Chain: Serialization, Counterfeits and Disposal of Expired Drugs
Speaker(s):
- Jésica Carino
  Fiscalizadora, Programa Nacional de Control de Mercado de
  Medicamentos y Productos Médicos, ANMAT, Argentina
- APEC Roadmap on Supply Chain Integrity
  Rafael Nevarez Nieves, MSc
  Assistant Regional Director, FDA Office Mexico
  FDA, Mexico

Day 2 Thursday, May 16, 2013

9:00AM - 10:00AM
Session 6: Transparency of Review Process

Session Chair(s):
- Jose Daniel Peña Ruz
  Regional Advisor, Medicines and Health Technologies PAHO/WHO
  Pan American Health Organization (PAHO)/World Health Organization (WHO), Chile
Session 6: Transparency of Review Process

Speaker(s):
- Mike Ward presentation
  Mike D. Ward
  Manager, International Programs Division
  Health Canada, Canada
- Larry Liberti presentation
  Larry Liberti, MS,RPh,RAC
  Director
  Centre For Innovation In Regulatory Science (CIRS), United States
9:30AM - 10:30AM
Session 7: Health Technology Assessment
Speaker(s):
- Mr. Alexandre Lemgruber presentation ~ via video conference
  Alexandre Lemgruber
  Regional Advisor, Health Technologies
  Pan American Health Organization (PAHO), United States
10:30AM - 11:30AM
Session 8: Implementation of e-Submissions
Speaker(s):
- Ines Elvira Ordóñez
  Medical Director
  Asociación de Laboratorios Farmacéuticos de Investigación, Colombia
- Cesar Masache, MD
  Head, National System on Pharmacotherapy & Pharmacovigilance
  Ministry of Public Health, Ecuador
- Areli Céron Sánchez
  Dictaminador Especializado - Ensayos Clinicos
  Comision Federal para la Proteccion Contra Riesgos Sanitarios (COFEPRIS), Mexico
12:00PM - 1:00PM
Session 9: Pharmacovigilance

Session Chair(s):
- Claudia Vaca, MD
  Advisor on Medicines
  Ministry of Health and Social Protection, Government of Columbia, Colombia
Session 9: Pharmacovigilance

Speaker(s):
- Columbian Pharmaceutical Policy and Pharmacovigilance
  Claudia Vaca, MD
  Advisor on Medicines
  Ministry of Health and Social Protection, Government of Columbia, Colombia
- Guatemalan Perspective
  Lily Gordillo, MSc
  Pharmacovigilance
  Ministerio de Salud, Guatemala
1:00PM - 1:15PM
Question and Answer for Session 9
2:00PM - 3:00PM
Session 10: Biosimilar Products/Generics and Bioequivalence
Speaker(s):
- Hans Vasquez presenation
  Hans Vasquez, MD
  Clinical Reviewer, New Medicine Application and Regulation of Biological Product
  Dirección General de Medicamentos Insumos y Drogas (DIGEMID) , Peru
- Laura Gomes Castanheira presentation
  Laura Gomes Castanheira
  Manager of Research and Clinical Trials
  COPEM/ANVISA, Brazil
- Ines Bignone presentation
  Ines Bignone, MD
  Director, Drugs Evaluation
  ANMAT, Argentina
3:00PM - 3:45PM
Session 11: Clinical Studies and Bioethics
Speaker(s):
- Cesar Masache, MD
  Head, National System on Pharmacotherapy & Pharmacovigilance
  Ministry of Public Health, Ecuador
- Nazly Cuevas Melendez, MD
  Medicines for Human Use Department, Clinical Trials Division
  Spanish Agency Medicine and Sanitary Products (AEMPS), Spain
- Areli Cerón Sánchez, MSc
  Dictaminador Especializado--Ensayos Clínicos
  Comisión Federal para la Protección Contra Riesgos Sanitarios (COFEPRIS), Mexico
4:00PM - 4:45PM
Session 12: "Miracle" Drugs and Pharmaceutical Products Bordering Dietary Suppliments
Speaker(s):
- "Miracle" Drugs and Pharmaceutical Products Bordering Dietary Supplements
  Rafael Nevarez Nieves, MSc
  Assistant Regional Director, FDA Office Mexico
  FDA, Mexico
4:45PM - 5:45PM
Session 13: Special Planning Session for the 6th Latin American Regulatory Conference (LARC)
Speaker(s):
- Mike D. Ward
  Manager, International Programs Division
  Health Canada, Canada
- Sergio Guerrero, MD
  Chair, DIA Advisory Council for Latin America
  President/CEO, Accelerium Clinical Research, Mexico
5:45PM - 6:00PM
Closing Remarks

Registration Fees

Other Fees

Charitable Nonprofit/Academia: $855.00
Government (Full Time): $652.00
Latin American Industry: $1205.00
Non-Latin American Industry: $1755.00

Group Discounts

IMPORTANT REGISTRATION DATES:

May 10, 2013: This is the last day for submitting registration payments via Wire Transfer or Check. Registrations made after this date will need to be paid via credit card.

May 13, 2013: Attendees who register after this date are requested to bring a copy of his/her registration confirmation and present it to the DIA registration in order for a badge to be created. Attendees who do not have his/her printed confirmation will not be allowed entrance.

On-Site Registration will be available at this meeting.

Register Online

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