What are the activities
during the Congress?

THURSDAY
24

WELCOME COCKTAIL

20:00 hrs. – 22:00 hrs.
Terraza Akumal, in the Cancun International Convention Center

FRIDAY
25

SCHEDULE

ROOM 1

ROOM 2

ROOM 3

8:00 – 9:00 hrs.

Registry

9:00 – 9:30 hrs.

Welcome by Organizers of the Event, Government, Academy, Industry.

9:30 – 10:30 hrs.

Master Lecture: Clinical Research, the Encounter of Two Worlds
Speaker: NR Kathy Lenhard, PanAmerican Clinical Research President

10:30 – 11:30 hrs.

Master Lecture: Research and Development of Medicines in the World, Challenges and Opportunities
Speaker: Dr. Gilberto Castañeda, Professor, Department of Pharmacology at Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional

11:30 – 12:00 hrs.

Coffee Break

12:00 – 13:00 hrs.

Research and Development of Biotechnological Medicines
Speaker: PhD Carlos Díaz Tufinio, Pharmacokinetics & Biostatistics Dept. Head at Axis Clinicals Latina

The Ethical Aspects of Clinical Research
Speaker: Dr. Simón Kawa Karasik, Director at Coordinación de Institutos Nacionales de Salud

Research Centers as a New Model of Business, Finance and Publicity
Speaker: Dr. Efrén Sánchez, CEO/General manager at General Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica at Yucatán

14:00 – 15:00 hrs.

Lunch

15:00 – 16:00 hrs.

Translational Medicine and Medical Professional Exercise
Speaker: Dra. Mirian Anel López Basilio, Vicepresident Colegio Médico de México

Pharmacoeconomy
Speaker: Dr. Juan Gabriel Gay, Director at TIS

Coordination of Clinical Research Centers
Speaker: MS Marcela Salazar, Study Coordinator Manager at iBiomed Guadalajara

16:00 hrs. – 16:45 hrs.

Contract and Budget in Clinical Trials (You don’t get what you deserve, you get what you negotiate)
Speaker: MBA Hakim Mohamed, CEO at One Source Clinical Management San Diego

Informed Consent Process
Speaker: Dr. Roberto Cruz Neri, Council Associate at Colegio de Especialistas en Cirugía General del Estado de Jalisco AC

Management of Clinical Research Projects in the Research Center
Speaker: BSc Linda Perez, Clinical Research Coordinator at Infinite Clinical Research

16:45 hrs. – 17:15 hrs.

Coffee Break

17:15 hrs. – 18:15 hrs.

Master Lecture: The importance of the SITE/CRO Relationship in Clinical Research
Speaker: PhD Diana Foster, CEO, Total Clinical Trial Management

18:15 hrs. – 19:15 hrs.

FDA 21 CRF part 11
Speaker: J.D. Mitchell E. Parrish, Vice President, Legal & Regulatory Affairs at Kinetiq, Food and Drug Administration expert

FRIDAY
25

8:00 – 9:00 hrs.

Registry

9:00 – 9:30 hrs.

Welcome by Organizers of the Event, Government, Academy, Industry.

9:30 – 10:30 hrs.

Master Lecture: Clinical Research, the Encounter of Two Worlds
Speaker: NR Kathy Lenhard, PanAmerican Clinical Research President

10:30 – 11:30 hrs.

Master Lecture: Research and Development of Medicines in the World, Challenges and Opportunities
Speaker: Dr. Gilberto Castañeda, Professor, Department of Pharmacology at Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional

11:30 – 12:00 hrs.

Coffee Break

12:00 – 13:00 hrs.

ROOM 1

Research and Development of Biotechnological Medicines
Speaker: PhD Carlos Díaz Tufinio, Pharmacokinetics & Biostatistics Dept. Head at Axis Clinicals Latina

ROOM 2

The Ethical Aspects of Clinical Research
Speaker: Dr. Simón Kawa Karasik, Director at Coordinación de Institutos Nacionales de Salud

ROOM 3

Research Centers as a New Model of Business, Finance and Publicity
Speaker: Dr. Efrén Sánchez, CEO/General Manager at General Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica at Yucatan

14:00 – 15:00 hrs.

Lunch

15:00 – 16:00 hrs.

ROOM 1

Translational Medicine and Medical Professional Exercise
Speaker: Dra. Mirian Anel López Basilio, Vicepresident Colegio Médico de México

ROOM 2

Pharmacoeconomy
Speaker: Dr. Juan Gabriel Gay, Director at TIS

ROOM 3

Coordination of Clinical Research Centers
Speaker: MS Marcela Salazar, Study Coordinator Manager at iBiomed Guadalajara

16:00 hrs. – 16:45 hrs.

ROOM 1

Contract and Budget in Clinical Trials (you don’t get what you deserve, you get what you negotiate)
Speaker: MBA Hakim Mohamed, CEO at One Source Clinical Management San Diego

ROOM 2

Informed Consent Process
Speaker: Dr. Roberto Cruz Neri, Council associate at Colegio de Especialistas en Cirugía General del Estado de Jalisco AC

ROOM 3

Management of Clinical Research Projects in the Research Center
Speaker: BSc Linda Perez, Clinical Research Coordinator at Infinite Clinical Research

16:45 hrs. – 17:15 hrs.

Coffee Break

17:15 hrs. – 18:15 hrs.

Master Lecture: The importance of the SITE/CRO Relationship in Clinical Research
Speaker: PhD Diana Foster, CEO, Total Clinical Trial Management

18:15 hrs. – 19:15 hrs.

FDA 21 CRF part 11
Speaker: J.D. Mitchell E. Parrish, Vice President, Legal & Regulatory Affairs at Kinetiq, Food and Drug Administration expert

SATURDAY
26

SCHEDULE

ROOM 1

ROOM 2

ROOM 3

8:00 - 9:00 hrs.

Breakfast with the Expert NR Kathy Lenhard, PanAmerican Clinical Research President

Breakfast with the Expert Dr. Federico Lerner, Head of Clinical Operations, LATAM, Covance

9:00 - 10:00 hrs.

The Development of Drugs in the UNAM, a National Alternative.
Speaker: Dr. Miguel Luján, Scientific Director of the Clinical Pharmacology Unit in UNAM School of Medicine.

10:00 - 11:00 hrs.

Master Lecture: What makes a site a good site? Operational Successes of Clinical Trials.
Speaker: BS. Mirna Del Valle Clinical Trials Specialist at Nestle Research Center (North and South America)

11:00 - 12:00 hrs.

Master Lecture: Generics Industry Transformation and Effects on CROs
Speaker: MBA Bjarni Baerings, CEO, Hetero Europe S.L.

12:00 - 12:30 hrs.

Coffee Break

12:30 - 13:30 hrs.

Patents: How to protect your Medicinal Product
Speaker: MSc Victoria Mejía, Patent Engineer at Olivares & Cia

Clincal Research Studies, How and When Developing them
Speaker: Dr. Roberto Cruz Neri, Council Associate at Colegio de Especialistas en Cirugía General del Estado de Jalisco AC

Patient Recruitment Strategy In Clinical Research Centers
Speaker: Dr. José Luis Pío, Clinical Trial Director at Avant Santé Research Center S.A.de C.V

13:30 - 14:30 hrs.

Monitoring studies based on risk, advantages and opportunities
Speaker: Federico Lerner, Head of Clinical Trial Operations, Latin America, at Covance

Importance of Pharmacogenetics and Pharmacokinetics in the Treatment of Children with Acute Lymphoblastic Leukemia
Speaker: Dr. Ismael Lares Asseff, Head of the Genomics Academy, National Polytechnic Institute.

Updates of Clinical Research in Applied Neurotechnology
Speakers: Dra. Diana Martínez y Dr. León Morales Quezada, Harvard University

14:30 - 15:30 hrs.

Lunch

15:30 - 17:00 hrs.

Round Table: Integral Strategy of Mexico to the World in the Field of Clinical Research.
Moderator: Marco Cid López, CEO Investigación Biomedica iBiomed Research Units

Speakers: 
Dr. Guillermo Caletti, Dra.Mirian López Basilio, Areli Cerón ,Dr. Simón Kawa Karasik and Dr. José Luis Pío

17:00 - 18:00 hrs.

Master Lecture: The Importance of the Research Ethics Committees at the Global Level
Speaker:
MSc. Areli Ceron, Operational Director of CONBIOETICA

18:00 - 18:30 hrs.

Coffee Break

18:30 hrs. - 19:30 hrs.

Entrepreneurship in Clinical Research
Speakers: Dr. Oscar M. Fonseca Rodríguez Director Division of the Business School. Technological Institute of Superior Studies of Monterrey Campus Santa Fe and Director of Business Alignment, Procliniq México S.A. de C.V.

 

Minimum Indispensable for a Clinical Research Center of Excellence
Speaker: M. Ed. Sharzy Molina Guizar, General Director at FAICIC

Statistical Requirements for Protocols
Speaker: PhD Nicole C. Close, President and Principal Biostatistician at Empiristat

21:00 hrs..

Special Event at Coco Bongo

SATURDAY
26

8:00 - 9:00 hrs.

Breakfast with the Expert NR Kathy Lenhard, PanAmerican Clinical Research President

Breakfast with the Expert Dr. Federico Lerner, Head of Clinical Operations, LATAM, Covance

9:00 - 10:00 hrs.

The Development of Drugs in the UNAM, a National Alternative.
Speaker: Dr. Miguel Luján ,Scientific Director of the Clinical Pharmacology Unit in UNAM School of Medicine

10:00 - 11:00 hrs.

Master Lecture: What makes a site a good site? Operational Successes of Clinical Trials.
Speaker: BS. Mirna Del Valle Clinical Trials Specialist at Nestle Research Center (North and South America)

11:00 - 12:00 hrs.

Master Lecture: Generics Industry Transformation and Effects on CROs
Speaker: MBA Bjarni Baerings, CEO, Hetero Europe S.L.

12:00 - 12:30 hrs.

Coffee Break

12:30 - 13:30 hrs.

ROOM 1

Patents: How to Protect your Medicinal Product
Speaker: MSc Victoria Mejía, Patent Engineer at Olivares & Cia

ROOM 2

Clincal Research Studies, How and When Developing them
Speaker: Dr. Roberto Cruz Neri, Council Associate at Colegio de Especialistas en Cirugía General del Estado de Jalisco AC

ROOM 3

Patient Recruitment Strategy In Clinical Research Centers
Speaker: Dr. José Luis Pío, Clinical Trial Director at Avant Santé Research Center S.A.de C.V

13:30 - 14:30 hrs.

ROOM 1

Monitoring Studies Based on Risk, Advantages and Opportunities
Speaker: Federico Lerner, Head of Clinical Trial Operations, Latin America, at Covance

ROOM 2

Importance of Pharmacogenetics and Pharmacokinetics in the Treatment of Children with Acute Lymphoblastic Leukemia.
Speaker: Dr. Ismael Lares Asseff, Head of the Genomics Academy, National Polytechnic Institute. 

ROOM 3

Updates of Clinical Research in Applied Neurotechnology
Speakers: Dra. Diana Martínez y Dr. León Morales Quezada, Harvard University

14:30 - 15:30 hrs.

Lunch

15:30 - 17:00 hrs.

Round Table: Integral Strategy of Mexico to the World in the Field of Clinical Research.
Moderator: Marco Cid López, CEO Investigación Biomedica iBiomed Research Units
Speakers: 
Dr. Guillermo Caletti, Dra.Mirian López Basilio, Areli Cerón ,Dr. Simón Kawa Karasik and Dr. José Luis Pío

17:00 - 18:00 hrs.

Master Lecture: The Importance of the Research Ethics Committees at the Global Level
Speaker:
MSc. Areli Ceron, Operational Director of CONBIOETICA

18:00 - 18:30 hrs.

Coffee Break

18:00 hrs. - 19:30 hrs.

ROOM 1

Entrepreneurship in Clinical Research
Speakers: Dr. Oscar M. Fonseca Rodríguez Director Division of the Business School. Technological Institute of Superior Studies of Monterrey Campus Santa Fe and Director of Business Alignment, Procliniq México S.A. de C.V.

 

ROOM 2

Minimum Indispensable for a Clinical Research Center of Excellence
Speaker: M. Ed. Sharzy Molina Guizar, General director at FAICIC

ROOM 3

Statistical Requirements for Protocols
Speaker: PhD Nicole C. Close, President and Principal Biostatistician at Empiristat

21:00 hrs..

Special Event at Coco Bongo

SUNDAY
27

SCHEDULE

ROOM 1

ROOM 2

ROOM 3

8:00 - 9:00 hrs.

Breakfast with the Expert: MBA Bjarni Baerings, Vice President at Hetero Europe S.L.

9:00 - 10:00 hrs.

Master Lecture: World Environment of Clinical Research, Challenges and Opportunities in a Globalized World
Speaker: Dr. Guillermo Caletti, Head of Clinical Operations Mexico, Central America & Caribbean Boehringer Ingelheim Mexico

10:00 - 11:00 hrs.

Challenges of the Recruitment Process in a Research Center: developing technological solutions.
Speaker: Dr. Carlos Augusto Pérez, Executive President of the Colombian Association of Clinical Research Centers, ACIC and Administrative Director, UNIENDO Research Center.

11:00 - 12:00 hrs.

The Importance and Processes of a CRO in the Field of Clinical Research
Speaker: Federico Lerner, Head of Clinical Trial Operations, Latin America, at Covance

12:00 - 12:30 hrs.

Coffee Break

12:30 - 13:30 hrs.

Research Ethics Committees
Speaker: Dr. Federico Ramos Ruiz, President of the Ethics Research Committee Instituto Tecnológico y de Estudios Superiores de Monterrey ITESM.

Strategies for the Development and Transformation of Clinical Research in Colombia.
Speaker: Dr. Carlos Augusto Pérez, Executive President of the Colombian Association of Clinical Research Centers, ACIC and Administrative Director, UNIENDO Research Center.

13:30 - 14:30 hrs.

Data Management in Clinical Research as a Competitive Advantage
Speaker: ENG. Vicente Alciturri, International Director at SEMICROL S.L

Good Clinical Practices Gcps E6 Ich with its last Updates
Speaker: Dra. Alma Minerva Pérez Ríos, Director at CIFE

Updates of Clinical Research in Applied Oncology
Speaker: Dr. Abraham Gerardo Cárdenas Roque, Oncologist and Researcher in Ibiomed and IMSS Ags.

14:30 hrs. - 16:30 hrs.

Closing Cocktail in Stand Area

SUNDAY
27

8:00 - 9:00 hrs.

Breakfast with the Expert: MBA Bjarni Baerings, Vice President at Hetero Europe S.L.

9:00 - 10:00 hrs.

Master Lecture: World Environment of Clinical Research, Challenges and Opportunities in a Globalized World
Speaker: Dr. Guillermo Caletti, Head of Clinical Operations Mexico, Central America & Caribbean Boehringer Ingelheim Mexico

10:00 - 11:00 hrs.

Challenges of the Recruitment Process in a Research Center: developing technological solutions.
Speaker: Dr. Carlos Augusto Pérez, Executive President of the Colombian Association of Clinical Research Centers, ACIC and Administrative Director, UNIENDO Research Center.

11:00 - 12:00 hrs.

The Importance and Processes of a CRO in the Field of Clinical Research
Speaker: Federico Lerner, Head of Clinical Trial Operations, Latin America, at Covance

12:00 - 12:30 hrs.

Coffee Break

12:30 - 13:30 hrs.

ROOM 1

Research Ethics Committees
Speaker: Dr. Federico Ramos Ruiz, President of the Ethics Research Committee Instituto Tecnológico y de Estudios Superiores de Monterrey ITESM.

ROOM 2

Strategies for the Development and Transformation of Clinical Research in Colombia.
Speaker: Dr. Carlos Augusto Pérez, Executive President of the Colombian Association of Clinical Research Centers, ACIC and Administrative Director, UNIENDO Research Center.

ROOM 3

13:30 - 14:30 hrs.

ROOM 1

Data Management in Clinical Research as a Competitive Advantage
Speaker: ENG. Vicente Alciturri, International Director at SEMICROL S.L

ROOM 2

Good Clinical Practices Gcps E6 Ich With Its Last Updates
Speaker: Dr. Alma Minerva Pérez Ríos, Director at CIFE

ROOM 3

Updates of Clinical Research in Applied Oncology
Speaker: Dr. Abraham Gerardo Cárdenas Roque, Oncologist and Researcher in Ibiomed and IMSS Ags.

14:30 hrs. - 16:30 hrs.

Closing Cocktail in Stand Area