5th Latin America Clinical Trials

Current Agenda

DAY ONE - August 18th, 2010

8:00
Seminar Registration Opens & Continental Breakfast is served for Seminar Attendees

9:00
FULL DAY Pre-Conference Seminar: QUALITY
Ensuring Quality within Clinical Processes:  Project Management for the Clinical Research Professional

WORKSHOP LEADERS:
Adriana Grosman
Clinical Research Professional
TEQUILA CLINICAL RESEARCH

Carlos Landulpho
Local Clinical Trials Coordinator
ROCHE Brazil

Prof. Clelia Magaril, MD
Medical Director
IMAI-RESEACH Argentina

Dr. Jorge Velasco
Principle Investigator and Site Manager
MEDICAL INSTITUTE CER OF QUILMES

TOPICS: PROJECT MANAGEMENT

• Defining Project Management and its context within business strategy
• Determining a level of risk/opportunity and uncertainty/complexity of a clinical research project
• Evaluating the economic-factors of research projects
• Project Management Considerations:
  • Defining project objectives
  • Cost management
  • Defining & communicating with key project stake holders
  • Appropriate delegation of study-related tasks

QUALITY ASSURANCE

• Defining quality in clinical research
• Identifying how compliance and quality drive organizational reputation and credibility
• Developing an organizational quality platform and long-term goals
• Role of the quality management team
• Introductions to operational excellence and it’s key definitions
• Timelines for implementing a quality plan
• Developing a culture of quality

HIGH PERFORMING INVESTIGATIONAL SITES

• Factors that can affect success
  • Experience
  • Workload
  • Trial Complexity
  • Number of subjects
  • Disease state
  • Number of studies conducted
  • Study purpose
  • Protocol
  • Investigational Product
  • Relevant tasks
  • Regulatory requirements
  • GCP/Declaration of Helsinki
  • Managing staff turnover

*There will be a morning and afternoon networking & refreshment break during the seminar in addition to lunch provided to all seminar attendees.


4:00
Close of Seminar/End of Day One

DAY TWO, Main Conference Begins

8:00
Main Conference Registration Opens & Continental Breakfast for Attendees

9:00
Chairperson’s Welcome and Opening Remarks

9:15 KEYNOTE PRESENTATION
The Global Clinical Research Landscape
Latin America as a Key Driver for Global Success: Opportunities and Challenges against the Global  Clinical Research Backdrop

Daniel Ciriano, Medical Director, ROCHE Argentina

• Regional value comparisons and criteria used by sponsors when selecting countries to conduct trials
• Corporate buy-in and the evolution of Latin America as a low-cost alternative region to conduct research to a crucial partner for long-term sustainability
• Joining the efforts of sponsors, health authorities, ethical committees, institutions, investigators, scientific societies and academia to benefit from a huge investment in R&D

10:00

Drug Access
Current Debate on the Pros and Cons of Providing Access to Drugs After a Trial is Completed

Fernando Alfieri Jr, MD, Regional Medical Director, PFIZER Brazil

• Current ethical guidelines, codes, declarations, and recommendations that
• drive drug access policy
• Geographical consistency where drug access is required at the both the
• subject and community levels
• Difficulties surrounding implementation of drug access
• Cost responsibilities
• Length of providing coverage – commercial availability
• Liability for adverse effects after study period

10:45
Networking & Refreshement Break

11:15
LATAM Regulatory Environment
Examining the Current Regulatory Timelines, Approval Processes and Ethical Committee Requirements within Different Traditional Latin America Countries to Ensure Compliance

This session will feature one session chair and three to four additional speakers providing content and promoting open audience participation. This session will provide guidance for working with regulatory agencies within different LATAM countries.

• Current regulatory authority and ethical committee procedures and timelines
• Local expertise and disease state prevalence
• Restrictions for study protocols
• Current trends

Moderated By:

Fernanda C. Durán, M.D., Executive Director, Latin American Operations, PHARMANET S.R.L.

Speakers:

	María Alejandra Azurmendi, Regulatory Affairs Head & DPOC, Argentina,Uruguay & Paraguay, SCHERING-PLOUGH and Organon, part of MSD Ignacio Maglio, Team Leader, Legal Medical Risk, F.J. Muñiz Hospital of Infectious Disease, Coordinator, Ethical Committee, Huesped Foundation
	Renato Ribeiro, Clinical Research Manager, MERCK
	Arturo Rodriquez, Director, INFINITE CLINICAL RESEARCH and Gabriela Rosas, Senior Regulatory Submissions Manager, Latin America Clinical Development Services, COVANCE

12:45
Lunch

2:00
Working in Non-Traditional LATAM Countries
Running Trials in Non-Traditional LATAM Markets: Shorter Timelines for Study Start-up and Regulatory Changes within Different Countries

Dra. Diana Valencia, MD, CEO and President, LATAM CLINICAL TRIAS. Inc.

• Unique characteristics of traditional vs. non-traditional countries
• Review of approval timelines within different countries and working with IRB’s
• Access to naïve populations and a prevalence of certain therapeutic areas/diseases
• Non-Saturation on the site level
• Research Certification

2:45
RESEARCH CERTIFICATION & INNOVATION
PANEL DISCUSSION: Examining the Necessary Steps and Avenues for Investigator Accreditation and Certification of Clinical Research Professionals in Latin America to Improve Clinical Performance

Led By:

Dr. Luis F. Collia, Medical Manager, MS Pharmaceutical Specialties, MERCK SERONO Argentina

Ezequiel Klimovsky, Owner, QUID-Consulting SRL

• Available training and certification options throughout different countries the region
• Who is responsible for seeking accreditation?
• Examples of certification programs in the US and Europe that have been successful

3:45
Networking & Refreshement Break

4:15
Evaluating the Current Picture of Site Certification Requirements in Colombia - Fully Understanding the Regulations and Implementing a Sustainable Solution

Claudia Chavarro, Associate Director Clinical Operations, Latin America, RPS

This session will evaluate site certification requirements in Colombia and focus on:

• Fully understanding the applicable MOH regulations to run clinical trials
• The two year implementation process necessary for MOH site certification
• The challeneges that newer investigative sites face to achieve certification

4:45
ROUNDTABLES
Select a preferred topic to discuss in an intimate setting.

1. What are the challenges for patient recruitment within established Latin America markets?  How to avoid saturation?

Andrea Buschiazzo, Project Management Director, KENDLE Argentina

2. Examination of key regulatory medical writing and submission issues in LATAM

3. How is the medical device regulatory landscape changing in Latin America and what are some issues to consider including intellectual property rights?

4. What are the pros and cons of providing access to drugs after a trial is complete?

Ana Paula Ruenis, PhD, Director, Clinical Operations Latin America, inVentiv Clinical Solutions LLC

5. Investigator Relationships

Tatiana Spollansky, Team Leader, ELI LILLY Interamerica, Inc.

María José Lago, Team Leader, ELI LILLY Interamerica, Inc.

5:30
End of Main Conference Day One

DAY THREE

9:00
Chairpersons’ Day Three Welcome & Recap

9:05 ROUNDTABLE RECAPS
PANEL DISCUSSION
Moderators from Roundtable Discussions Provide Key Points Addressed

9:45
AstraZeneca Case Study
Applying Lean Sigma to Low-Cost Countries to Reduce Cycle Times and Cost

Luis Rios Nogales Garces, MD, PhD, MBA, Regional Medical Director ISMO, Head, MCCD, Clinical Research Region, ASTRAZENECA LATIN AMERICA

10:45
Networking & Refreshment Break

11:15
Quality in Clinical Research
Fostering Quality when Conducting Trials in Latin America: Working with Investigators to Install a Quality Management System and Centralized Process

Anibal Salas Zarauz, MD, Senior Project manager/Country Lead, COVANCE

• Internally establishing a quality management team that ensures clinical quality
• Reviewing the characteristics of a strong investigational site staff that has the capabilities and resources to fulfill quality expectations
• Common quality oversights made by clinical monitors
• Ensuring accurate clinical records

12:00 PANEL DISCUSSION
Outsourcing Considerations
Service Provider Partnerships: From Outsourced to Integrated for Meeting the Company’s Strategic Global Trial Objectives

Moderated By:

Mariano Parma, Director, Strategic Development Latin America, PPD

Panelists Include:

Luis Rios Nogales Garces, MD, PhD, MBA, Regional Medical Director ISMO, Head, MCCD, Clinical Research Region, ASTRAZENECA LATIN AMERICA

Dr. Luis Ramirez, Regional Head Clinical Operations - Latin America, BOEHRINGER INGELHEIM S.A.

Carla Schlesinger, Regional Clinical Operations Manager, LACMASS Region, ELI LILLY Interamerica, Inc.

Catalina Vardaro, Clinical Site Manager, BRISTOL MYERS-SQUIBB Argentina

• Identifying outsourcing drivers in clinical research
• Working with a local CRO versus a global provider
• In-sourcing vs. Outsourcing benefits & drawbacks
• Strategies for enhancing communication with an outsourced partner to maximizing the investment

12:45
Lunch

1:45
Phase 1
The Current Environment for Phase 1 Studies in Argentina

Silvia del Rio, Clinical Operations Manager, RPS

This session will address the topic of Phase 1 trials in the Latin America region:

• The regulations and challenges relative to Phase 1 trials in the Latin America Region
• The investigative sites specializing in Phase 1 trials in the region
• The unique differences between Phase 1 and late Phase 2/3 studies

2:30
Current Clinical Research Trends that can Provide Insight into Future Developments for Latin America

Federico Lerner, M.D., Ph.D., Senior Director of Operations, Latin America, PRA INTERNATIONAL

• Metrics per country for research penetration - "Traditional" versus "Non-Traditional" activity
• Reasons provided for he growth and non-growth
• Insight into patient recruitment and site saturation

 
3:15 CLOSING PANEL
Ethical Considerations: Are Clinical Trials an Alternative to Medical Care in Latin America? Examining the Ethical Factors Behind  Clinical Research in Latin America 

Moderated By:

Mario Boskis, M.D., Director, Clinical Trial Department, Activa-CRO

Panelists Include:

Gabriel Zeitune, M.D., Director, Biostarting (former Director, DEMA, ANMAT)

Fernando Martinez, PhD, MBA, Executive Director of Global Operations, inVentiv Clinical Solutions LLC

Daniel Goldenberg, M.D., FCP, Director, Comité de Ética para Investigaciones Clínicas, Asociación Argentina de Investigaciones Ética

Fabian Dabove, M.D., Clinical Research Manager, Genzyme Argentina S.A.

• Are sponsors profiting off economic conditions?
• Lack of healthcare coverage
• Low quality of care
• Should there be different standards for clinical research in Latin America as opposed to other regions?

4:00
Close of Conference