Course Descriptions

Core Requirements:
Course No.

Title

Description

DRMD 0201* Pharmaceutical Products: survey of development principles and concepts (1 credit)* An introduction to the principles and activities that underlie the development of new medical products, including drugs, biologics, vaccine, medical devices and in vitro diagnostics
DRMD 0203*

Quantitative Methods Applied to Early Development Processes (1 credit)*

The fundamentals of epidemiology and biostatistics that are needed to develop and analyze clinical data obtained from early development activities, including characterization of the target population, adaptive design, and description of results from early testing
DRMD 0204* Quantitative Methods Applied to Late Development Processes (1 credit)* The fundamentals of epidemiology and biostatistics that are needed to conduct randomized controlled trials, including interim analyses and to conduct post-marketing studies, including cohort studies and registries; special topics: Baysean statistics for medical devices and testing in vitro test kits.
DRMD 0205* Clinical and translational pharmacology (1 credit)*                                                                                                                        The principles and activities that build an understanding of the pharmacokinetics and pharmacodynamics of new molecular entities, and the special issues posed by biologicals
DRMD 0207* Regulatory affairs and compliance (1 credit)*                        The principles and practices of regulatory strategy and logistics in representing a company to regulatory agencies; the processes needed to be internally compliant with SOPs and externally consistent with Good Regulatory Practices

Electives by Concentration:

Clinical Concentration

Course No.
 Title Description
DRMD 0202                                                                                                                                  Clinical trials overview (½ credit)* An introduction to the concepts, strategies and activities of clinical studies, from Phase 1 through Phase 4
DRMD 0251 Medical affairs (½ credit) The basic concepts needed to interface with non-company clinical investigators who are seeking company support to evaluate new clinical ideas
DRMD 0211 Project management (½ credit) The basic concepts and practices needed to evaluate and improve core processes in order to drive cost-savings, standardization, harmonization and greater productivity
DRMD 0208 Operations: clinical, regulatory, and pharmacovigilance (½ credit)                                       The basic operational activities that translate strategies into processes and procedures in conducting clinical trials, preparing documents for regulatory agencies, and conducting safety evaluations that are consistent with Good Operational Practices

Regulatory Affairs Concentration

Course No.
 Title  Description
DRMD 0223
Quality Assurance Oversight of Pharmaceuticals, Biologics, & Medical Devices (½ credit)
The principles of quality assurance as applied to the entire development enterprise
DRMD 0208
Operations: clinical, regulatory, and pharmacovigilance (½ credit)
The basic operational activities that translate strategies into processes and procedures in conducting clinical trials, preparing documents for regulatory agencies, and conducting safety evaluations that are consistent with Good Operational Practices

Safety Concentration

Course No.
 Title  Description
DRMD 0208 Operations: clinical, regulatory, and pharmacovigilance (½ credit)                           The basic operational activities that translate strategies into processes and procedures in conducting clinical trials, preparing documents for regulatory agencies, and conducting safety evaluations that are consistent with Good Operational Practices

Manufacturing and Devices Concentration

Course No.
Title
Description
DRMD 0242
Medical devices and in vitro diagnostics (½ credit)
The regulatory basis for developing and innovating the broad range of medical devices and in vitro diagnostics
DRMD 0241
Principles in manufacturing and quality (½ credit)
The principles, practices, and regulatory environment of commercial, industrial-scale manufacturing and quality of pharmaceutical products, including drugs and biologicals
DRMD 0223
Quality Assurance Oversight of Pharmaceuticals, Biologics, & Medical Devices (½ credit)
The principles of quality assurance as applied to the entire development enterprise
DRMD 0228
Operations: clinical, regulatory, and pharmacovigilance (½ credit)              
The basic operational activities that translate strategies into processes and procedures in conducting clinical trials, preparing documents for regulatory agencies, and conducting safety evaluations that are consistent with Good Operational Practices

R&D Management Concentration

Course No.
Title
Description
DRMD 0211
Project Management (½ credit)                                
The basic concepts and practices needed to evaluate and improve core processes in order to drive cost-savings, standardization, harmonization and greater productivity
DRMD 0251
Medical Affairs and Medical Information (½ credit)
The basic concepts needed to interface with non-company clinical investigators who are seeking company support to evaluate new clinical ideas

Business and Policy Concentration

Course No.
Title
Description
DRMD 0231
Ethics and bioethics in the pharmaceutical industry (½ credit)
The theories, principles and normative practices that are the basis of clinical studies and professional behavior with examples of critical failures
DRMD 0261
CER, OR and Pharmaco-economics (½ credit)                               
The basic concepts and practices of pharmacoeconomics by evaluating the costs and effects of pharmaceutical products through Outcomes Research and Comparative Effectiveness Research
 
DRMD 0263
Marketing principles, advertising & promotion (½ credit)
The process of planning and executing on the concept, price, and services used in marketing pharmaceuticals in a way that is consistent with the product label