Drug and Medical Device Development: A Strategic Approach

• Determine the best time to seek IP protection for ideas

• Learn the key sections of a patent and the outcome measures of products

• Discover the intended uses of medical products and how those are tested in clinical trials

• Gain further understanding of patent strategies

• Manage IP assets and navigate the complexities of product development in the pharmaceutical industry

• Design a quality study

• Apply quality systems to clinical trials

• Discover important regulatory pathways

• Gain a deeper understanding of design controls, documentation, and the intricacies of developing medical diagnostics

• Maintain high-quality standards, adhere to regulatory requirements, and effectively manage medical device development projects

• Evaluate diagnostics through sensitivity and specificity testing

• Discover biomarkers, the molecular or physical indicators of disease

• Understand what counts as wearable devices, how they are used, and what is needed to bring them to market

• Understand the challenges and breakthroughs in ovarian cancer screening, innovative colon cancer screening methods, and the complexities of obtaining reimbursement for medical tests

• Develop a comprehensive understanding of integrating innovative diagnostic technologies into the healthcare system, from development to market adoption

• Review software and hardware regulations, including the FDA's General Principles of Software Validation

• Identify key elements of drug discovery

• Recognize the target validation process for drug development

• Understand the essential processes of absorption, metabolism, transportation, and development in drug development and delivery

• Explore the evolution and impact of electronic health records (EHRs) on healthcare, as well as the role of AI in medicine, offering innovative solutions for patient care and data management

• Gain a deeper understanding of integrating technology, drug discovery, and pharmacokinetics in pharmaceutical development

• Validate the therapeutic index of drugs

• Understand formulations and how they ensure successful drug delivery

• Learn about drug stability: how drugs physically and chemically break down

• Examine parenteral products i.e., drugs injected directly into the body

• Explore biologics i.e., drugs produced from living organisms

How much time is required each week?

Each program includes an estimated learner effort per week. This is referenced at the top of the program landing page under the Duration section, as well as in the program brochure, which you can obtain by submitting the short form at the top of this web page.

How will my time be spent?

We have designed this program to fit into your current working life as efficiently as possible. Time will be spent among a variety of activities including:

• Engaging with recorded video lectures from faculty

• Attending webinars and office hours, as per the specific program schedule

• Reading or engaging with examples of core topics

• Completing knowledge checks/quizzes and required activities

• Engaging in moderated discussion groups with your peers

• Completing your final project, if required

The program is designed to be highly interactive while also allowing time for self-reflection and to demonstrate an understanding of the core topics through various active learning exercises. Please email us if you need further clarification on program activities.

What is it like to learn online with the learning collaborator, Emeritus?

More than 300,000 learners across 200 countries have chosen to advance their skills with Emeritus and its educational learning partners. In fact, 90 percent of the respondents of a recent survey across all our programs said that their learning outcomes were met or exceeded.

All the contents of the course would be made available to students at the commencement of the course. However, to ensure the program delivers the desired learning outcomes the students may appoint Emeritus to manage the delivery of the program in a cohort-based manner the cost of which is already included in the overall course fee of the course.

A dedicated program support team is available 24/5 (Monday to Friday) to answer questions about the learning platform, technical issues, or anything else that may affect your learning experience.

How do I interact with other program participants?

Peer learning adds substantially to the overall learning experience and is an important part of the program. You can connect and communicate with other participants through our learning platform.

What is the relationship between Emeritus and MIT xPRO?

Emeritus and MIT xPRO collaborate to create and deliver educational programs. None of these programs are Title IV-eligible.

What are the requirements to earn the certificate?

Each program includes an estimated learner effort per week, so you can gauge what will be required before you enroll. This is referenced at the top of the program landing page under the Duration section, as well as in the program brochure, which you can obtain by submitting the short form at the top of this web page. All programs are designed to fit into your working life.

This program is scored as a pass or no-pass; participants must complete the required activities to pass and obtain the certificate of completion. Some programs include a final project submission or other assignments to obtain passing status. This information will be noted in the program brochure. Please email us if you need further clarification on any specific program requirements.

What type of certificate will I receive?

Upon successful completion of the program, you will receive a smart digital certificate. The smart digital certificate can be shared with friends, family, schools, or potential employers. You can use it on your cover letter, resume, and/or display it on your LinkedIn profile.The digital certificate will be sent approximately two weeks after the program, once grading is complete.

Can I get the hard copy of the certificate?

No, only verified digital certificates will be issued upon successful completion. This allows you to share your credentials on social platforms such as LinkedIn, Facebook, and Twitter.

Do I receive alumni status after completing this program?

No, there is no alumni status granted for this program. In some cases, there are credits that count toward a higher level of certification. This information will be clearly noted in the program brochure.

How long will I have access to the learning materials?

You will have access to the online learning platform and all the videos and program materials for 24 months following the program start date. Access to the learning platform is restricted to registered participants per the terms of agreement.

What equipment or technical requirements are there for this program?

Participants will need the latest version of their preferred browser to access the learning platform. In addition, Microsoft Office and a PDF viewer are required to access documents, spreadsheets, presentations, PDF files, and transcripts.

Do I need to be online to access the program content?

Yes, the learning platform is accessed via the internet, and video content is not available for download. However, you can download files of video transcripts, assignment templates, readings, etc. For maximum flexibility, you can access program content from a desktop, laptop, tablet, or mobile device.

Video lectures must be streamed via the internet, and any livestream webinars and office hours will require an internet connection. However, these sessions are always recorded, so you may view them later.

Can I still register if the registration deadline has passed?

Yes, you can register up until seven days past the published start date of the program without missing any of the core program material or learnings.

What is the program fee, and what forms of payment do you accept?

The program fee is noted at the top of this program web page and usually referenced in the program brochure as well.

• Flexible payment options are available (see details below as well as at the top of this program web page next to FEE).

• Tuition assistance is available for participants who qualify. Please email learner.success@emeritus.org.

What if I don’t have a credit card? Is there another method of payment accepted?

Yes, you can do the bank remittance in the program currency via wire transfer or debit card. Please contact your program advisor, or email us for details.

I was not able to use the discount code provided. Can you help?

Yes! Please email us with the details of the program you are interested in, and we will assist you.

How can I obtain an invoice for payment?

Please email us your invoicing requirements and the specific program you’re interested in enrolling in.

Is there an option to make flexible payments for this program?

Yes, the flexible payment option allows a participant to pay the program fee in installments. This option is made available on the payment page and should be selected before submitting the payment.

How can I obtain a W9 form?

Please connect with us via email for assistance.

Who will be collecting the payment for the program?

Emeritus collects all program payments, provides learner enrollment and program support, and manages learning platform services.

Are there any restrictions on the types of funding that can be used to pay for the program?

Program fees for Emeritus programs with MIT xPRO may not be paid for with (a) funds from the GI Bill, the Post-9/11 Educational Assistance Act of 2008, or similar types of military education funding benefits or (b) Title IV financial aid funds.

What is the program refund and deferral policy?

For the program refund and deferral policy, please click the link here.

The Drug and Medical Device Development program from MIT xPRO is an eight-week learning journey that builds a strong foundation in the drug discovery and development lifecycle for the pharmaceutical and biotech industries — from concept to market launch.

Upon completion of the program, you will receive a digital certificate from MIT xPRO, demonstrating advanced, industry-relevant skills. This program does not offer any official pharmaceutical or drug development certification.

The Drug and Medical Device Development program from MIT xPRO is designed for working professionals in life sciences, pharmaceutical industry roles, and adjacent biotech industries looking to gain expertise in the drug development process, expand career prospects, or accelerate career advancement.

Professionals do not necessarily require a background in health sciences, pharmacy, or pharmaceutical sciences to enroll in the program. However, it can be beneficial in building specialized knowledge and a foundational understanding of preclinical testing, the clinical trial process, and drug application.

Global professionals can enroll in this MIT xPRO program and progress at their own pace. It also offers networking opportunities with peers worldwide and updates on the latest advancements shaping healthcare and biopharma sectors.

Many entry-level care credentials, including basic first aid/CPR or support-focused roles, can be earned in a matter of weeks. However, the Drug and Medical Device Development program offers advanced learning in the drug discovery and development process, granting a professional MIT xPRO certificate in eight weeks. It is not a clinical or regulatory medical certification.