Event Calendar

Agenda

Clinical Research / Clinical Science Course

You may choose to attend Module 1 (only), Module 2 (only), or Module 1 and 2


For a printable PDF agenda, click here.  

MODULE 1 – Regulatory / Procedural 

(Monday, Tuesday & Wednesday)

Monday - 8:00 a.m. to 4:30 p.m.
 

Issues Involved in Addressing the Drug Development Process

 Review and discussion regarding the definitions, regulations and processes from IND to NDA.

Speaker: Patricia Beers Block, MDEd, BS, BS, CCRP, Assistant Professor, Rutgers University, School of Health Professions

ICH Guidelines

 Discussion regarding the development and implementation of the International Committee on Harmonisation, the clinical research guidelines resulting from that collaboration, and how the ICH Guidelines affect the clinical researcher.

Speaker: Patricia Beers Block, MDEd, BS, BS, CCRPAssistant Professor, Rutgers University, School of Health Professions

Study Development and the Research Budget

 Review of the (drug, device, biologics) development program, including protocol development, data collection, project and program management, and assessing costs and building budgets. How to develop budgets and strategies for managing costs (at the investigational site). Clinical Research billing compliance from the perspective of a study coordinator will be briefly discussed.

Speaker: Bryan Soronson, BS, MPA, Senior Administrator, Department of Neurology, University of Maryland Medical Center


Tuesday - 8:00 a.m. to 4:30 p.m.

Clinical Pharmacology and AE Reporting

 Understanding the presentation and detection of adverse drug events, the pharmacodynamic and pharmacokinetic mechanisms of reactions, methods of causality assessment, safe medication practices in clinical research, and a review of FDA and OHRP guidance on adverse event reporting.

Speaker: John Kessler, PharmD, Chief Clinical Officer, SecondStory Health

Source Documentation and Administration 

Review of procedural and management issues regarding utilization and dispostion of source doucments. 

Speaker: George D'Addamio, PhD, President, ParmConsult, Inc. 

IRBs and the Informed Consent Process

Discussion of regulations, generall accepted policies and procedures, and audit practices associated with IRBs and the informed consent process.

Speaker: George D'Addamio, PhD, President, ParmConsult, Inc. 


Wednesday - 8:00 a.m. to 4:30 p.m.

Good Clinical Practices (GCP) and Preparing for a GCP Audit

Perspectives and regulations regarding adherence to protocol, patient rights, informed consents, and regulatory issues related to an FDA audit.

Speaker: George D’Addamio, PhD, President, PharmConsult, Inc.

Research Ethics

 The importance of the informed consent and the principles of medical research ethics are discussed as well as therapeutic misconceptions, randomizations, and placebos.

Speaker: Victor Santana, MD, Vice President, Clinical Trials Administration, St. Jude Children’s Research Hospital

 

 

 

 

 

 

 

 

MODULE 2 – Medical / Scientific

(Wednesday 1:00 PM to Friday 4:30 PM)

Wednesday - 1:00 p.m. to 4:30 p.m.

Research Ethics

 The importance of the informed consent and the principles of medical research ethics are discussed as well as therapeutic misconceptions, randomizations, and placebos.

Speaker: Victor Santana, MD, Vice President, Clinical Trials Administration, St. Jude Children’s Hospital


Thursday- 8:00 a.m. to 4:30 p.m.

Cell Biology

 Understanding cell structure, function, and reproduction.

Speaker: Richard Sloane, MS, Durham Technical Community College

Genetics and Pharmacogenetics

 A review of the development and science supporting these interventions.

Speaker: Richard Sloane, MS, Durham Technical Community College

Anatomy and Physiology

Overview of selected body systems and organs and how they function.

Speaker: Richard Sloane, MS, Durham Technical Community College


Friday- 8:00 a.m. to 4:30 p.m.

Analysis of Laboratory Values

A review of basic laboratory values and their importance in the disease process.

Speakers: 

 Kazunori Murata, PhD, Memorial Sloan-Kettering Cancer Center

Samuel McCash, MD, Memorial Sloan-Kettering Cancer Center

Epidemiology and Statistical Issues

The study of the distribution and determinants of health related events in certain populations.

Speaker: Brad Pollock, PhD, Professor and Chairman, Department of Epidemiology and Biostatistics, School of Medicine, University of Texas Health Science Center at San Antonio; Associate Director for Cancer Prevention, San Antonio Cancer Institute