Fast Track Your Career in the Pharmaceutical And Medical Device Industries
The NanoDegree in MDRA is the premier Program for medical professionals who want to want to build a career in Medical Devices. You’ll gain the skills you need to plan and implement a Device regulatory aspects, learn to translate your research into clinical practice, and build a career on the frontiers of health care.
The NanoDegree in MDRA is aimed at students who have undergraduate degrees in various branches of engineering and wish to apply their background knowledge and skills to the development of medical devices. The programme is interdisciplinary bringing in and developing both engineering knowledge and the biomedical applications of this knowledge. The programme will equip graduates for immediate employment within the biomedical engineering sector, both in the nationally and internationally. Device regulatory aspects and biomedical ethics will be taught as underpinnings to the engineering and biomedical elements.
The NanoDegree in MDRA brings together candidates from a range of fields including design, health care, engineering and business, and prepares graduates to play a leading role in the development of emerging medical devices. Graduates of the NanoDegree will have:
- Learn current methods used in drug development including molecular therapies, novel formulation, clinical trials design and analysis, and personalised medicine.
- Develop an understanding of pharmacoeconomic, pharmacovigilance and pharmacoepidemiology related to drug development.
- Explore the full scope of medicine and medical device registration processes, from therapeutic guidelines, regulation, documentation, and post-registration follow up to the range of technologies and medical devices that exist, their properties, classifications, development and manufacturing requirements.
- Prepare and critically evaluate regulatory submissions, clinical trials, and drug registration information
The programme focuses on the interdisciplinary nature of Medical Device Regulatory Affairs, covering topics ranging from basic medical science and bioinstrumentation to product design and human factors. At the core of the programme is a focus on the needs of people in healthcare. Through a range of studio projects students learn to conduct human centered contextual research, extract meaningful insights, create and visualise concepts, and develop and evaluate prototypes, all in the context of the complex and highly regulated world of medical device design.
Covering the theoretical and practical aspects of the discipline, the course encourages students to design from a human centred perspective while gaining a deep understanding of the underlying science, technology, materials and manufacturing processes which underlie medical device design and development.
You will be taught by an experienced teaching team whose expertise and knowledge are closely matched to the content of the modules on this course. The team includes senior academics and professional practitioners with industry experience. The following group of staff members are currently involved in the delivery of different elements of this course. This pool is subject to change at any time within the academic year.
The course structure and flexibility assists you to extend, integrate and apply your core knowledge and skills with depth across the broad domain of clinical practice and research, something that students want in a highly competitive industry and employers have identified as important.
|S.No.||Subject Code||Title||Module Content||Total Credits|
|1||BSMDRA 1601||Essentials of Medical Devices||Medical Devices: Definition & Lifecycle||2|
|Strategic Planning in Regulatory Affairs||1|
|Principles of Medical Device Regulatory Affairs||1|
|Design, Development and Certification of Medical Devices||3|
|Therapeutic Product Development: A Regulatory Overview||2|
|Clinical Evaluation of Medical Devices||1|
|Regulation of Generic Pharmaceutical and Biosimilar Products||2|
|Drug-device Combinations and Other Technologies||1|
|Medical Devices: Advertising and Promotion||2|
|2||BSMDRA 1602||Medical Devices Regulations Globally||Regulation of Biomedical Product Commercialization by Health Canada||2|
|Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview||3|
|Medical Devices: US Regulations||2|
|Medical Devices: EU Regulations||2|
|Global and Operational Impact of Electronic Common Technical Document (eCTD) Submissions||1|
|Medical Devices: Compliance & Audits||2|
|European Union Compliance Process and Regulatory Affairs||2|
|Medicines Regulatory Harmonization in Africa||1|
|Medical Devices: Corrections, Removals and Directed Recalls||2|
|3||BSMDRA 1603||Regulatory Strategy||Global Regulatory Strategy for Medical Devices||2|
|Regulatory Strategy for a New Active Substance: Nonclinical Development||2|
|Registration of Biological, Biotechnology and Advanced Therapy Products||2|
|Leadership and Strategic Management in Regulatory Affairs||2|
|Regulatory Strategy for a New Active Substance: Global Clinical Development||2|
|Legal Issues in International Food, Drug, and Medical Device Regulation||2|
|Regulatory Strategy for Established Active Substances||2|
|Regulatory Strategy in the Post Market Phase||2|
|Regulatory Strategy: From Development to the Market Place||2|
|4||BSMDRA 1604||Risk Management & Post Market Surveillance||Medical Devices: Postmarket Surveillance||1|
|Post Market Surveillance and Vigilance for Medical Devices||2|
|Emerging Product Categories in the Regulation of Drugs and Biologics||3|
|Real-World Evidence in Biomedical Research||2|
|Project Management in Early Drug Discovery and Development||2|
|Medical Devices: Risk Management||2|
|5||BSMDRA 1605||IVDs Regulations||Biomedical Product Development: From Biotech to Boardroom to Market||2|
|Regulation of Combination Products||3|
|Regulation of IVDs for Key International Markets||2|
|Regulation of IVDs in the US and UK||3|
|Risk Management: Compliance and Processes||2|
|Regulation of In vitro Diagnostic Medical Devices||3|
|6||BSMDRA 1606||Quality Assurance and Compliance||Data for Abridged Applications and Specialised Products||2|
|Product Development and Process Validation||3|
|Emerging Trends and Issues in the Medical Device Industry||2|
|Fundamentals of CMC Regulations and Methods||2|
|Application of Quality System Regulation in Medical Device Design and Manufacturing||2|
|Data Management and Digitalisation in Regulatory Affairs||2|
- Graduate/Post Graduate degree in Pharmacy/ Pharmaceutical Science
- Graduate/Post Graduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology)
- Graduate or Equivalent degree in Nursing/Allied Health
- Students in their Final Year of Graduation for the above courses may also apply.
The minimum time in which a student can complete this diploma course is 06 months while a maximum of 12 months is allowed to complete the course.
Assessment of students will be through continuous assessment of each module, which will include written assignments, team-based assignments, and open-book exams using multiple choices, matching questions as well as short and long answer questions. All the participants are obliged to timely submit completed assessment assignments (during the course, usually after every module) and appear for an online exam at the end of the course. After successful completion, the participants will be awarded Skilled Nano-Degree in MDRA by BBMInstitute.
After the completion of the NanoDegree Program, a wide array of professional opportunities awaits the students. The program has been designed to ensure that the knowledge you gain can be applied to current industry needs and be readily integrated into your day-to-day work.
Graduates of this course will have the opportunity to move into careers in different areas of the pharmaceutical and medical device development industry including:
- Research & Development (including pre-formulation and formulation
- Quality Control and Quality Assurance
- Regulatory, medical and scientific affairs
- Clinical trials
- Marketing and sales