Purpose of this Certificate Program
To provide practical hands-on training for candidates interested in a career in medical and regulatory writing.
Target Audience
University of Findlay students interested in pursuing a career in medical writing or learning the skills required for medical writing.
Prerequisites
Completion of a minimum of three years academic coursework in a life science or health science field, or permission of the instructor.
Minimum Expectations:
- Understanding of scientific writing (e.g., through manuscripts, posters/abstracts, grant writing).
- Must have a strong understanding of the Microsoft® Office suite.
- Strong desire to understand fundamentals of regulatory writing and the regulatory environment.
Intended Learning Outcomes
- Describe the United States drug development process
- Explain the general drug approval process
- Explain how clinical trials are designed
- List the components of a clinical trial
- Write a clinical study protocol (CSP)
- Write a Clinical Study Report (CSR)
Description of Training Provided
This is a comprehensive hands-on course for the clinical and regulatory focused individual in the pharmaceutical industry that will allow you to apply your skills to almost any regulatory document. This 8-week course provides students with an overview and best practices for writing clinical study protocols and clinical study reports, two of the most common document types in contemporary medical writing. Topics also include a detailed background on the drug approval process and additional insights into the tools of the trade. Templates, ICH guideline content requirements and standard industry guidelines will be covered. This is an excellent program for the scientist interested in a career as a medical or regulatory writer in the pharmaceutical industry and a continued learning opportunity for the writer already working in the field.
Duration
8 weeks
Assessments
Knowledge checks will be performed through quizzes at the end of each session. Evaluation of student outputs will be performed through various assignments and exercises, concluding with a final examination. A minimum of 75 percentage points is required to pass the final examination and obtain certification.
Purpose of this Certificate Program
To train and educate professionals in the field of clinical trial disclosures for reporting to public registries mandated by law and regulated by health authorities.
Target Audience
University of Findlay students wishing to specialize in trial disclosures.
Prerequisites
Completion of a minimum of three years academic coursework in a life science or health science field, or permission of the instructor.
Intended Learning Outcomes
- Describe the United States drug development process
- Explain disclosure landscape, with an awareness of legal and ethical framework
- Define a process to effectively conduct summarizations of different types of clinical trial protocols and results following registry guidelines
- Define rules for reviewing, interpreting, and summarizing Protocols, Clinical Study Reports, data tables, listings, and graphs
- Discuss interface capabilities, technical components, and timelines for disclosing on domestic and international registries
- Define a process for operationalizing clinical trial disclosure workflow
Description of Training Provided
This eight-week course provides training and education for professionals in the field of clinical trial disclosure reporting. This is an evolving regulatory requirement in which the Life Science industry has struggled to maintain compliance; because of its complexities, outsourcing has increased. The skill sets required to learn and excel in disclosures are the focus of this program. This course will provide hands-on experience with writing and reporting to global registries with an emphasis on Clinicaltrials.gov (US) and EudraCT (EMA). Students will learn about the legal and ethical basis for disclosure of the clinical trial protocol and results, beginning with a comprehensive overview of Clinicialtrials.gov and EudraCT. The course will define how to meet the technical requirements of the registries, to effectively summarize protocols and results. Other mandatory international registries will also be reviewed, and workflow processes and systems for operationalizing clinical trial disclosures will be demonstrated. This is an ideal course for the detail oriented, regulatory-focused, compliance-minded scientist or aspirant within the pharmaceutical industry.
Duration
Eight weeks
Assessments
Knowledge checks will be performed through quizzes at the end of each session. Evaluation of student outputs will be performed through various assignments and exercises, concluding with a final examination. A minimum of 75 percentage points is required to pass the final examination and obtain certification.
Purpose of this Certificate Program
Writing the clinical documents of a standard new drug application (NDA) requires an understanding of the drug development process, a strong grasp of scientific principles, and the ability to write clearly and effectively. Our hands-on course for clinical and regulatory-focused individuals in the pharmaceutical industry will allow you to apply your skills to the clinical documents in an NDA submission.
Target Audience
University of Findlay students interested in pursuing a career in medical writing or learning the skills required for medical writing.
Prerequisites
Completion of a minimum of three years academic coursework in a life science or health science field, or permission of the instructor.
Intended Learning Outcomes
- Describe new drug development in the United States
- Explain what are the different types of NDA (New drug approval)
- Explain the role of clinical data in the NDA
- Explain the regulations and guidelines
- Describe how to write clinical summary
- Describe how to write clinical efficacy documents
- Describe how to write clinical safety documents
- Describe how to write clinical overview
- Explain benefit and risk section of NDA
- Describe how to write ancillary clinical documents in an NDA
Description of Training Provided
Writing the clinical documents of an standard new drug application (NDA), requires an understanding of the drug development process, a strong grasp of scientific principles, and the ability to write clearly and effectively. It also requires a grasp of the type of data included in each module as well as the key purpose each section serves.Our hands-on course for clinical and regulatory-focused individuals in the pharmaceutical industry will allow you to apply your skills to the clinical documents in an NDA submission. This 8-week course will focus on learning how to interpret and organize clinical data and write standard clinical documents in an NDA submission.
Duration
8 weeks
Assessment
Knowledge checks will be performed through quizzes at the end of each session. Evaluation of student outputs will be performed through various assignments and exercises, concluding with a final examination. A minimum of 75% is required to pass the final examination and obtain certification.