Pharmaceutical professionals keep one foot in science and another foot in health authority regulation, both rapidly evolving fields that require consistent training to keep pace. In addition, new opportunities often entice scientists to widen their expertise to contribute to new areas of drug development, which may require an entirely new set of skills. At some point, you are likely to reach the limit of what your corporate or personal budget for training allows, and at that point this list is just what you are looking for: quality training that is either free or subsidized!
These courses are ones I have taken and felt were worth the time investment. This list is current as of September 2019.
This course is offered by the NIH to train new clinical investigators from October to June of each year. It covers all aspects of clinical trials including design, analysis, reporting, budgeting, regulations, and ethics. The textbook is available for about $75 and the course is free, self-paced, and entirely online. If you pass the final exam you will earn a certificate of completion. This course is a significant time commitment, there are about 40 lectures and most are 60-90 minutes, and you will need to allot additional time to reading the assignments and studying for the exam. I highly recommend going through Statistics on Khan Academy (see below) to prepare for the biostatistics in this course.
This 6-week course offered by the Office of Regulatory Affairs and Quality (ORAQ) at Duke University is free and available online via WebEx. Each session starts around September, but you can register as early as February. This course is not self-paced, there are 1-hour webcasts from 12-1 pm EST on Fridays. They take attendance and there is reading and homework.
ORAQ also offers free seminars on regulatory topics that you can join via WebEx.
This online course consists of 6 self-paced modules, which took me about 6 weeks (they estimate 8 weeks). It’s a great overview of the drug approval process and the history of the FDA. It’s presented by the Program on Regulation, Therapeutics, and Law at Harvard and Brigham and Women’s Hospital. It is free to audit, or $99 to get a certificate. This course starts again October 3, 2019. It is self-paced, so you start anytime enrollment is open.
The FDA offers free online resources, including the online courses below.
Dr. Kristin Sainani of Stanford teaches this excellent free self-paced course that starts with a brief review of statistical concepts, then uses medical case studies to challenge your interpretation of statistics in clinical reports. After this course, you will be better able to understand and critically evaluate statistical claims in journal articles and clinical study reports. It’s 23.5 hours, but well worth your time. Dr. Sainani is an excellent teacher, I enjoyed several aha! moments in this course when she was explaining the mathematical underpinnings of statistics.
If you are completely new to medical writing, this $75 course will provide a complete overview to the field. It’s available online through ed2go through partnership with community colleges.
When writing up adverse events, you need to learn a whole other language. If you are new to terms like pyrexia, dyspnoea, and tachycardia, take this brief online self-paced course on the Latin and Greek behind medical terminology. It takes about 2 hours, and is free if you don’t require a certificate.
Government communications are required to be written in plain language, but some writers are unclear what plain language means. This free online self-paced course provides clear examples of how to use plain language in health communications, and exercises for you to practice. There are 8 modules, each module takes approximately 30 minutes.
Membership to AMWA will cost you $195/year, but offers a lot of educational perks for medical, scientific, or regulatory writers. AMWA offers a variety of paid courses, but there are some that are free for members (search for “pocket training” or “complimentary“), and they email out a monthly free webinar (one that is usually paid) for members as well. You also get an included subscription to the AMWA Journal, all back issues online, and proceedings of the past annual conferences are summarized and posted online. Membership in AMWA also includes free chapter events that are a great bargain if you live near an active chapter.
Membership in the North Carolina Regulatory Affairs Forum is only $40 and includes 6 seminars per year on regulatory topics that are available by WebEx. They also offer a summer workshop (at an additional very reasonable fee) to prepare for the Regulatory Affairs Certification (RAC) exam.
This podcast is provided by Emma Hitt Nichols of Nascent Medical to promote her business and her 6-week course. She has many interviews with medical writers, and through listening you can learn about the many career paths available to medical writers as well as many tricks of the trade.
This podcast, sponsored by PSI, is excellent for statisticians and those who work with statisticians, and some episodes on leadership and influence are applicable to anyone in pharma.
Take a whirlwind tour of the past, present, and future of cancer in episode #62 of Peter Attia’s podcast. I’ve listened to this one a few times because so much interesting detail is packed into every minute of this episode.
This free magazine will keep you up to date on news, regulatory updates, and best practices for Chemistry, Manufacturing, and Controls (CMC).
This is a great monthly email newsletter for medical writers full of tips, tricks, and tools.
The European Medical Writer’s Association journal published an entire issue devoted to regulatory writing in 2014, and it’s free for non-members to read.
Trilogy has several publications written by expert medical writers on a variety of topics.
Emma Hitt Nichols’ book on Freelance Medical Writing
Emma broadcasts a free webinar regularly to promote her 6-week course. The course is not free, but when I attended her webinar she provided her book for free to attendees.
Know of a great cheap or free course that I should list here? Contact me through the contact link above and let me know! Happy learning!