The British BioMedicine Institute Skilled NanoDegree Program in “Clinical Trials, Pharmacovigilance and Regulatory Affairs (CTPRA)” offers a systematic, academic qualification in Clinical Research, above all in connection with the approval of new pharmaceutical and medical devices. The interdisciplinary approach aims to improve practical interaction between different academic disciplines.
In Skilled NanoDegree Program “CTPRA” students learn the competencies required for planning, implementing and evaluating clinical tests with drugs and medical devices (self- competence, professional competence, social and communicative competence, legal and regulatory frameworks) at an internationally required level of education by means of practice-oriented classes, seminars and lectures. Practitioners and experts from the clinical research field resp. other related academic disciplines, combined with active teaching methods, ensure that course participants receive internationally sought-after practical training in clinical research to prepare them for a management role. Students acquire the core competence monitoring and, subsequently, auditing clinical trials.
Programme Structure – 71 Credits
The lecturers of this Skilled NanoDegree Program are distinguished experts and Practitioners from relevant disciplines (clinicians, Project Managers, CRAs, etc.). This particularly ensures that the connection to current Clinical Research practice is as close as possible.
Target Group For Skilled NanoDegree
- Physicians, pharmacists, biologists, chemists, psychologists and other university graduates seeking a leading position in clinical research
- Specialists already working in Clinical Research (including Clinical Research Associates and Monitors)
- People involved in Clinical Research studies at test centers – e.g. Study Nurses – or those who aim to work in this area
- People working in Biotechnological And/Or Pharmaceutical Companies in Research & Development, or who aim to work in this area
- People who work or aim to work in CROs
- Employees of Regulatory Bodies who need to acquire or upgrade essential knowledge and practical skills in Clinical Research for their control work
- Members and employees of Ethics Commissions who want to acquire or upgrade specialized knowledge and skills for their work
- Employees in Biotechnological, Pharmaceutical and/or Medical Engineering Companies who want to acquire specialized knowledge for a leading position primarily in the field of Research & Development
- Pharmaceutical representatives who want to upgrade their professional expertise for Research And Development
We welcome students from all over the world and consider all applicants on an individual basis.
Please note: applications will be considered on a monthly rolling basis and you will hear back from the School once a decision has been made.
- Video blogs
- Articles and case study reviews
- Individual and group presentations
- MCQs and online quizzes
- Mini research project
- Reports and paper reviews
- Written examinations
Clinical Research is an expanding and highly competitive area. Undertaking this Skilled NanoDegree (CTPRA) will provide you with the skills and knowledge needed to advance and enhance a career in Clinical Research.
This programme is suitable for graduates from healthcare, life sciences or other related disciplines, and healthcare professionals who are interested in a career in Clinical Trials in the Health Service, Pharmaceutical, Biotechnology, Device Industries, Contract Research Organisations/ Suppliers to the Pharmaceutical Industry. It is also ideal for professionals working in Clinical Trials who wish to further develop their knowledge and skills of Clinical Trials.
Potential career opportunities include Clinical Trials, Clinical Research, Clinical Data Management, Regulation Of Clinical Trials, Medical Writing, Academic Clinical Trials, Phase I Clinical Trials Units, The Pharmaceutical Industry, Hospitals, Archiving In Clinical Trials, Quality Assurance In Clinical Trials, Clinical Research Project Management, Clinical Trial Administration, Clinical Trial Co-Ordinator, Clinical Trial Administration/Support To Clinical Trials and more.
After successfully completing this NanoDegree program, you will have an advanced standing both clinically and academically, with the potential to be at the forefront of your chosen profession.
BSCR-CTPRA 1301 Basic Introduction to Clinical Research
BSCR-CTPRA 1302 Basic Pharmacology and Pharmaceutical Medicine
BSCR-CTPRA 1303 Guidelines for Clinical Trials (ICH-GCP)
BSCR-CTPRA 1304 Drug discovery & Development and Pre-Clinical Studies
BSCR-CTPRA 1305 Ethics In Clinical Research
BSCR-CTPRA 1306 Roles And Responsibilities In Clinical Trials
- Heath and Human Services regulations(HHS)
- Roles & Responsibilities of Ethics Committee
- Roles & Responsibilities of Investigator
- Roles & Responsibilities of Clinical Research Coordinator
- Roles & Responsibilities of Sponsor
- Roles & Responsibilities of CRA/Monitor
- Roles & Responsibilities of Auditor
- Roles & Responsibilities of Clinical Data Manager
- Roles & Responsibilities of Clinical Biostatistician
BSCR-CTPRA1307 Clinical Trial Preparation
BSCR-CTPRA 1308 Essential Documents And Regulatory Submission
- Improving Patient enrollment and retention
- New Drug Application(NDA): Pre NDA meeting , NDA submission Check list , FDA NDA review check list
- Investigational New drug (IND): Classifications, IND application submission check list, FDA IND review check list , IND application process, Information for sponsors-investigator submitting IND, IND forms and instructions
- Orphan Drugs Application : Submission check list, FDA orphan drug review check list , FDA documents
BSCR-CTPRA 1309 Study Start-up & Procedures in Clinical Trial
- Abbreviated New drug Application(ANDA): ANDA content, ANDA Submission check list , FDA ANDA review check list , ANDA process for generic drugs, guidance documents for ANDAs, ANDA forms and electronic submissions
- Site Initiation Visit (SIV)
- Site Selection Check list
- Site Monitoring Visit (SMV)
- Site Close Visit (ScV)
BSCR-CTPRA 1310 Clinical Trials Documents
BSCR-CTPRA 1311 Compliance And Audits
BSCR-CTPRA 1312 Data Management And Biostatistics
BSCR-CTPRA 1313 Regulatory Affairs In Clinical Research
- Query Management and DCF Resolution
- schedule Y for toxicity studies
- Structure and mandate of FDA
- e-CTD (Common Technical Document)
- Drugs Controller General of India (DCGI)/Central Drugs Standard Control Organization (CDSCO) submissions,
- FDA and DCGI Guidelines-Vaccine,Diagnostic and surgical Trials
BSCR-CTPRA 1314 Medical Device Trials
BSCR-CTPRA 1315 Project And Vendor Management
- Budgeting of Clinical Trials
- Roles and responsibilities of a Project manager
- Project Management matrix, Business development strategies
- Site Selection Criteria- Site Selection parameters: Location, Staffing, Qualifications, History, Clinical trial experience, Area of therapeutic experience, Investigational pharmacy, ICH-GCP compliance.
BSCR-CTPRA 1316 Pharmacovigilance and reporting Drug Safety