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 ppportunities
Speaker: Dr. Gilberto Castañeda, Professor, Department of hharmacology 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 Tufino, 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, President of Federación Nacional de Colegios Médicos 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 Tufino, 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, President of Federación Nacional de Colegios Médicos 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

9:00 – 10:00 hrs.

The vision of the pharmaceutical industry facing the new challenges in the Clinical Research
Speaker: BSc José Rivelino Flores, Director of regulatory affairs and Innovation, Canifarma

10:00 – 11:00 hrs.

Master Lecture: Clinical studies in Latin America, how to become an attractive destination without failing in the attempt
Speaker: Dr. Mario Coll, Senior clinical operation manager at AbbVie

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

Clinical research studies, how And when developing them
Speaker: Dr. José Luis Pío, Clinical trial director at Avant Santé Research Center S.A.de C.V

13:30 – 14:15 hrs.

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

Pharmacovigilance in clinical research, sponsors and research centers
Speaker: MSc Everardo Vázquez Moreno, Regional director of pharmacovigilance at Pfizer; President at AMF

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

14:15 – 15:15 hrs.

Lunch

15:15 – 16:45 hrs.

TBD

16:45 – 17:15 hrs.

Coffee Break

17:15 hrs. – 18:15 hrs.

Uses of mass media for clinical research
Speaker: Lic. Miguel Ángel Ramírez, General director at SEEC LA

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

9:00 – 10:00 hrs.

The vision of the pharmaceutical industry facing the new challenges in the clinical research
Speaker: BSc José Rivelino Flores, Director of regulatory affairs and innovation, Canifarma

10:00 – 11:00 hrs.

Master Lecture: Clinical studies in Latin America, how to become an attractive destination without failing in the attempt
Speaker: Dr Mario Coll, Senior clinical operation manager at AbbVie

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

Clinical Research studies, how And when developing them
Speaker: Dr. José Luis Pío, Clinical trial director at Avant Santé Research Center S.A.de C.V

13:30 – 14:15 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

Pharmacovigilance in Clinical Research, sponsors and research centers
Speaker: MSc Everardo Vázquez Moreno, Regional director of pharmacovigilance at Pfizer; President at AMF

ROOM 3

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

14:15 – 15:15 hrs.

Lunch

15:15 – 16:45 hrs.

TBD

16:45 – 17:15 hrs.

Coffee Break

17:15 hrs. – 18:15 hrs.

ROOM 1

Uses of mass media for Clinical Research
Speaker: Lic. Miguel Ángel Ramírez, General director at SEEC LA

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.

The impact of the design of Clinical Research studies on the access of new drugs. European application lessons in Latin America
Speaker: Joaquín F. Mould, Global health economics and outcomes research director / RWE strategy lead oncology at Bayer Pharmaceuticals

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.

Constitution And Functioning Of Research Ethics Committees or IRB
Speaker: Dr. Federico Ramos Ruiz, President of the Ethics Research Committee Instituto Tecnológico de Monterrey

Updates of Clinical Research in applied oncology
Speaker: TBD

Updates of Clinical Research in applied cardiology, stem cells and angioginesis
Speaker: Dr. Melvin Martínez Castrillón, Cardiologist at Martinez-Castrillon Cardiology

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 autoimmune diseases
Speaker: Dra. Adriana Sánchez, Rheumatologist at iBiomed

14:30 hrs. – 15:00 hrs.

Congress Closure

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.

The impact of the design of Clinical Research studies on the access of new drugs. European application lessons in Latin America
Speaker: Joaquín F. Mould, Global health economics and outcomes research director / RWE strategy lead oncology at Bayer Pharmaceuticals

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

Constitution And Functioning Of Research Ethics Committees or IRB
Speaker: Dr. Federico Ramos Ruiz, President of the Ethics Research Committee Instituto Tecnológico de Monterrey

ROOM 2

Updates of Clinical Research in applied oncology
Speaker: TBD

ROOM 3

Updates of Clinical Research in applied cardiology, stem cells and angioginesis
Speaker: Dr. Melvin Martínez Castrillón, Cardiologist at Martinez-Castrillon Cardiology

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 autoimmune diseases
Speaker: Dra. Adriana Sánchez, Rheumatologist at iBiomed

14:30 hrs. – 15:00 hrs.

Congress Closure