Clinical Trials Regulatory Affairs
The laws and guidelines that regulate the clinical research, marketing approval, manufacture, and advertising of drugs, biologics, and medical devices are complex and ever-changing. Regulatory Affairs professionals interpret and utilize these regulations throughout a drug/device lifecycle in order to bring a product to the market. Regulatory Affairs professionals write technical documents, review advertising and labeling, and are involved with regulations governing the manufacturing of products. The goal of the program is to prepare students to interpret regulations, conduct regulatory filings, and gain a thorough understanding of policies governing product development
Regulatory Affairs professionals are involved in every stage of the drug/device lifecycle, applying a regulatory framework to product development. They prepare regulatory submissions to the authorities, review product claims, and assess compliance with regulations. They may also be involved in post-market surveillance and the development of risk-minimization plans. Regulatory Affairs individuals may also monitor compliance in the manufacturing arena.
Competencies for Regulatory Affairs:
· Develop and submit applications for permission to study and market products to a variety of international and national regulatory agencies
· Interpret regulations involved in the investigation, production, labeling and distribution of drugs, food, additives, medical devices, biological products, pesticides and other similar products, and provide guidance on these rules to the project team
· Assist in protocol development to satisfy new requirements for post-marketing commitment studies
· Understand the various regulatory documents involved in pharmacovigilance
· Develop Regulatory Strategies that enable the launch of drugs in foreign markets
· Identifying concepts involved with GXP as it relates to Good Manufacturing Practices (GMP), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs); Outline the steps in a preventive action investigation by documenting the background of the issue and to identify a corrective action to the deviation and a suggested timeline of completion
Clinical Trials Recruitment Sciences
This track teaches the knowledge and skills necessary to become a Clinical Research Associate/Monitor (CRA) or a Clinical Research Coordinator (CRC) who is able to manage the growing number of clinical drug trials both in the US and abroad. Students will learn to develop strategies for patient recruitment and retention, and test out the validity of these methods scientifically, with the goal of safely speeding up the drug approval process. The overall goal for the Clinical Trial Management & Recruitment Track is for students to acquire the knowledge and skills necessary for effective clinical trial management from both sponsors and study site perspectives.
Clinical Research Associate (CRA) are individuals designated by sponsors (pharma company) to monitor the progress of a clinical investigation. They are employees of a pharma company or work for a CRO (Contract Research Organization). CRAs can also be independent contractors. Most have a bachelor’s or master’s degree in natural or medical sciences. CRA tasks include editing protocols for studies, writing informed consents, assuring that principles of Good Clinical Practice are adhered too, selecting investigational sites, and conducting study initiation, monitoring visits and closeout.
Clinical Research Coordinator (CRC) are professionals designated by the principal investigator to lead a study at the site level. They are involved with study start-up, subject recruitment, screening patients, and enrollment, as well as implementation and data management. They may also negotiate the study budget with the CRA and submit to the IRB. CRCs may also create study documents like subject tracking logs, medication tracking logs, and organize study binder and source documents. The CRC is responsible for collecting data and making sure the study is conducted as outlined by the sponsor.
Competencies for the Clinical Trial Recruitment Sciences:
· Demonstrate knowledge of pathophysiology and pharmacology
· Interpret the appropriate portion of the CFR and use this document to guide the execution of Clinical Research professional
· Conduct study specific activities for a study and conduct protocol feasibility such as preparing case report forms/electronic data capture, storage of study materials and documents, informed consent documents, as well as budget, close-out procedures and perform post study analysis
· Design and monitor recruitment campaigns with an understanding of influences such as disease, pharmacogenomics, culture and religion
· Research and test methodologies used for patient recruitment to develop evidence based approaches to this study area
· Formulate a business plan for a clinical trial including managing external funding, budgeting processes, cost-benefit and cost-effectiveness data
· Demonstrate a working knowledge of databases used to capture outcomes, biomarkers, and endpoints from the site investigators
· Design a quality assurance plan to coincide with study initiation procedure
Drug Safety and Pharmacovigilance
Drug Safety specialists are needed to develop tools to identify adverse drug reactions at an earlier stage in development, recognize signals that suggest adverse drug reactions, and effectively create
risk-minimization tools. Every drug, biologic, and medical device has a risk-to-benefit ratio. Some risks are known early in the development phase and can be predicted by preclinical studies. However, many safety issues first come to light only after large-scale clinical trials are conducted in the post-marketing phase of development. As drug recalls grow, there has been a greater emphasis on identifying signals both in the clinical phase of study and after the product has been released on the market. The overall goal is to prepare the students to assist in recognizing, quantifying, analyzing, and communicating adverse events to the proper regulatory authorities, and to develop mitigation strategies to prevent future adverse events.
Drug Safety Officer/Pharmacovigilance Specialists monitor the safety of drugs, biologics, and medical devices. They review reports of adverse events from patients, regulatory agencies, healthcare professionals, and investigational sites, and then write safety reports for the Healthcare Authorities. They are also involved in data mining to screen for adverse events (signal detection) and assess the risk and benefits of medical products, as well as develop risk management plans. A clinical background is preferred as well as a thorough understanding of the regulatory requirements both in the US and abroad. However, there are individuals who may fill positions in drug safety departments who are involved with data collection, report writing and quality management and do not necessarily require past clinical experience.
Competencies for the Drug Safety & Pharmacovigilance Track
• Analyze differences in safety regulations/guidances between different global regions • Analyze adverse events based on seriousness and labeledness/ expectedness • Prepare drug safety narrative • Describe the key drug safety reporting requirements that must be filed with a regulatory agency • Perform risk identification (signal detection) and characterize identified risks, potential risks based on signal analysis to develop a risk management plan • Identify the different Risk Management Tools such as RMPS and REMS • Describe databases containing adverse drug events, such as MedDRA and Eudravigilance and explain how they are used