MSHS in Regulatory Affairs

[00:12:08.50] JENNIFER KELLNER: From this program, graduates will leave George Washington University with the experience and competence to “provide strategic direction and integrate business needs in matters of regulatory science and affairs,” “lead and collaborate with functions and stakeholders for effective development of medical products,” “understand the philosophies and roles of the domestic and international regulatory agencies that oversee drug, biologic, device, and diagnostic development,” and “evaluate the scientific and economic value of bringing new health care products into the global market.” “The flexibility was key. I found the online discussion boards to be even more useful than face-to-face discussions, as they were archived, allowed time for review and reflection, and allowed all people to contribute equally, even the soft spoken individuals in real life.” Current student.

[00:13:08.95] DANIELA DRAGO: So the curriculum of the master program consists of six core regulatory affairs courses. And I will show them to you in a minute. Then we have two graduate research courses. Those are biostatistics, then epidemiology, and then three strategic leadership courses.

[00:13:31.92] Those are courses which have graduate students across health sciences, including physicians, MBA students, and other scientists. And then there is an elective option. So here is a list of our core regulatory first courses. We start with an introduction to global regulatory affairs and then move to regulatory strategy in the development of drugs and biologics as well as regulatory strategies in the development of devices and diagnostics, clinical research regulatory affairs, regulatory compliance, and leadership and change in regulatory affairs.

[00:14:15.97] JENNIFER KELLNER: “My learning experience with George Washington University has been exceptional so far. Yesterday, I was informed that I obtained a Regulatory Affairs position in my company, Actavis. I was able to perform well in the interview thanks to all I have learned. I believe that many professionals who are looking to start a regulatory affairs career can benefit from the GW program as I did.” Graduate in 2016.

[00:14:41.85] OK, so at this point now, if you have questions, please go ahead and type them in the box at the bottom. And we’ll go ahead and get those answered for you. And we do actually already have one. So Dr. Drago, our first question is, “Is a master’s in Regulatory Affairs good for a job along the lines of data safety management?”

[00:15:07.60] DANIELA DRAGO: I would say yes. We do have, for example, some people that have worked in data safety. They’re in the management or even in drug safety or– it’s one of these related field where if you’re knowledgeable about the regulations and how to deal with the regulated– with the regulators and with the regulated industry, in case you would like to have that job on the regulator’s side, then this is often considered a great advantage. There are other options, but definitely a master in Regulatory Affairs is a very good one.

[00:15:45.36] JENNIFER KELLNER: Thank you for that, Dr. Drago. We also have another potential student asking if there are any sorts of face-to-face or blended opportunities that are either part of the program or an option.

[00:15:58.59] DANIELA DRAGO: Absolutely. We do have a very exciting opportunity, I think, which we organized as an elective course in collaboration with the European Central Pharmaceutical Medicine at the University of Basel in Switzerland. So what we do is [AUDIO OUT] and meet a lot of top leaders in the field. We also go to visit FDA, NIH, and last year, we even went to Congress. And the next time we will offer this course, which is called Issues and trends in regulatory science. It’s a Summer Institute. It’s going to be in August, 2018.

[00:16:50.17] JENNIFER KELLNER: Great, thank you for that. We have somebody asking about the admissions requirements, which I can go over. So basically, the first step is to talk to an admissions representative such as myself to make sure everything’s a good fit so we can send a recommendation forward with your file.

[00:17:07.78] And then in order to enter the system, what we’re looking for is a resume. And then for you to just start filling out the basic information in our application, we do have a team of application specialists now that are there to help you along the process, get transcripts, letters of recommendation. So you will need copies of all transcripts. Even if you had transfer credits that show up on another transcript, we do need each official.

[00:17:34.93] We also will need two letters of recommendation, at least one from some kind of a supervisor, either past or present, and then the other one can be either academic or professional. We just ask that they’re signed and on letterhead. And then there is also a brief essay portion, which is a statement of purpose.

[00:17:51.88] And basically that is your opportunity to really talk about your background and then your goals and motivation for wanting to take on a program of this caliber. We have another question, Dr. Drago, that is, “How does international regulatory affairs differ from domestic regulatory affairs? Is there a difference if someone wants to take a job in another country?”

[00:18:23.61] DANIELA DRAGO: [INAUDIBLE] what happens, it depends on the role. So yes, there are differences between domestic regulatory affairs versus international. Regulatory affairs, it’s a lot of laws and regulations that are on the basics, are different depending on the jurisdiction.

[00:18:46.79] JENNIFER KELLNER: OK, thank you. We have another–

[00:18:49.47] DANIELA DRAGO: Science, law, and business.

[00:18:53.27] JENNIFER KELLNER: Dr. Drago, can you say that again? I think you cut out a little bit there during the response.

[00:18:59.23] DANIELA DRAGO: OK, so I wanted to say that there are differences in regulatory affairs on the domestic and the international side because if you consider that the field is a combination of science, law, and business, and that law is different depending on the jurisdictions, a lot of the regulations can be different depending on the geographic region.

[00:19:27.07] That being said, many roles nowadays are so-called global roles where individuals are asked to have an overview of different type of regulations in different jurisdictions. And this is the approach that we have in the curriculum. So you will not learn only about the FDA, but also about the EMA in Europe and the PMBA in Japan, and all these elements are intertwined in the curriculum.

[00:20:00.85] JENNIFER KELLNER: Thank you, Dr. Drago. We have another question if it’s possible to complete the program in a year.

[00:20:10.29] DANIELA DRAGO: It is possible to do this graduate certificate in a year. And we had students that have been able to do that. Typically, students choose the graduate certificate instead of the master if they already have, for example, a terminal degree, a high degree, so it’s not– they are not necessarily looking to get yet another master, but time is of the essence. And they want to show commitment to this profession. So they rather choose to join us for a year and take the graduate certificate.

[00:20:55.88] JENNIFER KELLNER: Thank you. We also then have another question here. As an online participant, how are we able to meet with the FDA?

[00:21:08.57] DANIELA DRAGO: Yes– one option, for example, is to join the Summer Institute, where we are going– we bring the students to visit the agency. Also, some of our faculty are FDA officials. And they meet students sometimes at professional societies or other type of events where one can network.

[00:21:39.29] JENNIFER KELLNER: Perfect, thank you. We have a couple of questions about admissions. So there is no GRE required. And in terms of– someone was asking about how long it takes and how you find out once you have been submitted and accepted. And basically, we try to kind of do rolling admissions so that poor Dr. Drago doesn’t have 100 files all at once that she’s looking through.

[00:22:06.17] So as we send those up every two weeks or so, then she does the best she can with turnaround. And then not only will you see your answer in the application portal, but we will actually also give you a call and let you know your decision and then start getting you ready for next steps, registration, all that kind of stuff as well. We have another question where somebody is asking, “If you have no work experience in regulatory affairs, can you do two letters of recommendation from professors?”

[00:22:40.44] Yeah, we have very few students that have no experience at all in the field. But when I mean the field is, it’s not necessarily only regulatory affairs. It could be, for example, we have students that already have a working knowledge of either the pharmaceutical industry or the medical device industry so that their letter of recommendation, for example, could come from the head of quality or somebody from drug safety or other functions are related. I must admit it’s a bit hard to get admitted to the program if the individual has absolutely no experience in the health care industry. And that’s because, on average, our students have at least eight years of experience.

[00:23:45.42] JENNIFER KELLNER: Perfect. And along those same lines, Dr. Drago, can you kind of talk about, from your perspective, what you’re looking for in an ideal candidate– what type of experience or what type of background, really works well with this program?

[00:24:00.42] DANIELA DRAGO: Yeah, I think our student body is pretty diverse. In average, what we have as students are people, maybe 30% of our students are already working professionals in the pharmaceutical industry. 30% are in the medical device, and then around 20% have worked at the FDA or for another regulatory agency. And the rest is maybe employed by a contract manufacturer or a contract research organization.

[00:24:40.35] And typically, we’re not looking– because all the students are very different, we don’t have an ideal candidate. But besides a knowledge of the health care industry, of the health care enterprise in general, what the admission committee is looking at are also strong writing skills and the ability of crafting a message in a way that is persuasive but still clear and succinct. And the reason why is that those type of skills are really important in the profession.

[00:25:25.34] JENNIFER KELLNER: Perfect, thank you. We have another question about if there’s any prerequisites that are required before starting the program.

[00:25:35.87] DANIELA DRAGO: No, we do not have any type of prerequisites.

[00:25:40.34] JENNIFER KELLNER: OK. We have another question, “Do we have a chance to communicate with other students?” Maybe kind of talk a little bit about how the online learning is actually set up. Yeah, so the entire program is set up and designed in a way where it can be all taken asynchronously.

[00:26:03.37] So you will– nobody will ever be forced to be at that certain time, at the certain place or online for a mandatory opportunity. That being said, we also offer a lot of venues where students, our students and faculty can interact. And this can be done either online through guest lectures or other opportunities, but also at professional presentations, local chapters. And we really fostered that so that we can have that globalized learning community.

[00:26:50.48] JENNIFER KELLNER: Perfect. We also have somebody asking about if, in terms of letters of recommendation, if they work for different departments, if it matters if they get a manager to write one from one department versus another or anything like that. And as far as the admission side goes, I would say no, unless you have anything different Dr. Drago. I simply just like to see at least a supervisor in general.

[00:27:19.28] DANIELA DRAGO: I think what the admission committee likes to see are letters that are very specific. So when you ask someone to write a letter for you, my recommendation would be ask someone that knows you well and can substantiate their statements with specific examples. So if someone says, oh, this person is an excellent writer or an excellent presenter, this has a different type of impact than if the person says, yeah, this candidate is an excellent presenter because I saw him providing this presentation that landed us this type of deal with a client for our consulting company. So anything that can be very specific and full of examples does a different impact.

[00:28:19.86] JENNIFER KELLNER: Thank you. Another student is asking if it’s possible to take two courses at a time. The way we restructured the program is that rather than letting students taking two courses in parallel, courses can be taken in sequence. So in a 15-week typical semester, rather than having two 15-weeks courses, you would take– in parallel, you would take two 8-week courses in sequence.

[00:28:52.80] DANIELA DRAGO: We discourage students to take two 8-weeks courses in parallel because we thought that very few, if none, have been able to be successful with that model. So it’s a way to protect the student and set them up for success.

[00:29:16.26] JENNIFER KELLNER: Thank you. We have another question here about where students typically end up after the program, career-wise, and what sort of support there is in terms of resume writing or job placement, things like that.

[00:29:31.92] DANIELA DRAGO: Yeah, so we have an internal Listserv where we circulate a lot of job opportunities. What happens is, and this is back to the fact that we have a great advisory board, really, for the program and the fact that our graduates have been so successful. Now, company, they proactively reach out to us before they even posted their ads because they want to be put in contact with our students and graduates early on.

[00:30:05.52] So this is something that we definitely do. And in terms of success stories, a lot of our students, a lot of our graduates then, some of them I have in mind right now are, for example, commissioner fellows at the FDA or work for companies like GSK, Pfizer, [INAUDIBLE], the Stryker, Medtronic, you name it.

[00:30:32.61] JENNIFER KELLNER: Very good. Do you often see students that are interested in regulatory affairs for areas outside of pharmacy go through the program? Or what would be a related field that somebody could get into this program with?

[00:30:47.90] DANIELA DRAGO: OK. Often we have people that are currently working either in a quality control or quality assurance position or our design engineers or those type of roles, where they have contact with the regulations. And with regulatory, it’s just [? tangent ?] maybe at the beginning. But then they get interested in the field and they are looking for an opportunity to make a switch. And often the switch happens in the same company.

[00:31:26.47] JENNIFER KELLNER: Thank you. We have another question about whether or not you would even consider an applicant that just got their bachelor’s degree, or if you’re looking for experience first.

[00:31:36.81] DANIELA DRAGO: We are really looking for experience first. And the reason why is because there are other programs out there that are tailored more to very junior professional or fresh graduates. And because the pace and the level of our courses is tailored to people that are already experienced, we see that experience is not there, students struggle.

[00:32:02.94] So an opportunity that we do to accommodate sometimes is to say, OK, rather than applying right away after graduation, why don’t you sum up some practical experience because that practical experience then also emphasizes and helps a lot with the academic experience you can have at GW. The two things go hand in hand and then can really [? accelerate. ?]

[00:32:35.55] JENNIFER KELLNER: Thank you. Is there any distinction between an online master’s degree, such as Regulatory Affairs, versus a brick and mortar program in your experience?

[00:32:46.57] DANIELA DRAGO: I don’t know. I think I– from what I hear from students is that the online experience can be sometimes more [AUDIO OUT] anticipating because a lot is done– it’s in writing. So sometimes, for example, during discussion boards, in a brick and mortar environment, you can just say something and maybe not be so precise or accurate. And that’s not possible in an online environment because the faculty will be scrutinizing every word you wrote.

[00:33:26.08] So although it can be more tough from one perspective, it also can enhance the learning experience because it will then provide an opportunity to retain and look at more information during the program. But I would say it really depends on the individual. Some individuals tried more in one environment and others in another environment.

[00:33:55.19] JENNIFER KELLNER: Thank you. Can you talk a little bit about whether or not there’s a thesis or a final project or a test of some sort at the end of the program?

[00:34:06.01] DANIELA DRAGO: Yes, we do have a capstone project. And the capstone course is a leadership course. So in the context of the course, students are asked to develop– change proposal, leadership change proposal. So this is what they do as their final assignment.

[00:34:32.18] JENNIFER KELLNER: Thank you. Can you give some examples of different entry level salaries that you tend to see when people are fresh out of the program?

[00:34:42.65] DANIELA DRAGO: It depends, really, on where they were coming from because if you entered the program and you are at the specialist level, and then once you exit, you are at the master level– sorry, at the manager level, your salary will be very different than somebody that enters the program already as a director, and then gets promoted to vice president once they are finished. And because, again, our student population is so different, then this is hard to give a range.

[00:35:13.71] But in terms of what are the salary range for regulatory professionals, there are data that are published from the Regulatory Affairs Professional Society. And there are often regular surveys that the society does. And I think we even have a link on our GW website to that survey. So you can look at some data there.

[00:35:41.49] JENNIFER KELLNER: Thank you. Any advice for applicants that are looking to join the program that don’t have that experience already?

[00:35:51.21] DANIELA DRAGO: Yes. There are opportunities for either internships. It depends also on the location of the student. But let’s say, for example, for people that are in the DC, the greater DC areas, there are opportunities to do internships also at the FDA or with smaller organizations. Sometimes also clinical research organizations, such as PPV or Parexel. They have the entry level internships where one can work on projects. And sometimes it’s even possible to do some type of volunteering experience. We also consider that as experience when a candidate has that.

[00:36:40.35] JENNIFER KELLNER: Thank you. Can you share some success stories? Any favorites from the years?

[00:36:48.76] DANIELA DRAGO: Yeah, I think what is also really nice is that we do have a community. So we get in touch and we hear often from our graduates. And one of our recent graduates, for example, wrote me recently, and she’s currently working at FDA. And I know she got an important award. So it was very nice that she shared that achievement with us.

[00:37:14.52] And then we often hear about promotions or people that go out and have recognitions from professional societies are invited to speak at conferences or publish on [INAUDIBLE] journals. So those are some of the really nice success stories we hear regularly.

[00:37:42.47] JENNIFER KELLNER: Very good. Can you also give some examples of some different projects or assignments that students can expect through the program?

[00:37:51.44] DANIELA DRAGO: Yes. We do have in the program a combination of academic assignments and more professional assignments. So although, in some courses, you will be asked to write a term paper or an essay, you will also have a lot of opportunities to solve case studies– so those are real life case studies or hypothetical scenarios– and write sections of an investigation on your drug application or some [INAUDIBLE] application. So you can already build a portfolio that then will enhance the opportunity to learn maybe the job in regulatory affairs.

[00:38:39.08] JENNIFER KELLNER: Thank you. We have another question about whether or not being a pharmacist for several years is sufficient for the experience needed for this program.

[00:38:51.03] DANIELA DRAGO: Yeah, we do have a lot of really successful Pharm. Ds that moved from the typical pharmacist job to a regulatory affairs position. And many of them are really very successful because they do have that knowledge of the health care enterprise from a different perspective. But then they can bring it to the program with a different tact. So yes, definitely yes.

[00:39:23.40] JENNIFER KELLNER: OK, thank you. We have a question about F1 visas and the requirements for foreign students. So that’s a question I can answer, actually. For an online program, we are actually not able to give any type of visa since the program can be attended from anywhere in the world. So if you’re in another country, you can easily log in anywhere in the world. It’s completely asynchronous.

[00:39:49.77] You’ll have your deadlines, you’ll see everything in advance, and you can kind of plan your time depending on the particular time difference. But unfortunately, unless you come on campus, we can’t really do anything in terms of visas. We have another question here asking about what sort of– let me see here. It says, “You mentioned there are some programs that are tailored towards newer professionals, and this is looking for people with work experience. For someone who just graduated with a bachelor’s, what kind of advice do you have for them?”

[00:40:30.20] DANIELA DRAGO: I think it’s important to look at your options and see also what fits best your needs and your objectives. What I can tell you from the perspective of– who has been in the position to recruit people working for my regulatory affairs department while I was in industry, I typically had more– for me it was more important to have someone that had a good and solid academic background, but also experience.

[00:41:09.63] And so I think that that’s a bias that is still in the industry and where I think it’s very hard to work around it. That being said, there are options out there that look– that do provide the master without any type of a requirement in terms of experience.

[00:41:35.66] JENNIFER KELLNER: Thank you. Can you talk a little bit about the benefits and differences between the full master’s and the certificate?

[00:41:44.08] DANIELA DRAGO: Mm-hmm. I think I touched upon that earlier. But in a nutshell, the master, I think, is something that this– where we have the majority of our students. And in the graduate certificate, one of the advantages is that it’s shorter. And sometimes we offer it to students that already have a terminal degree and so they don’t necessarily want to have yet another master under their belt.

[00:42:23.34] JENNIFER KELLNER: OK, thank you. Can you talk a little bit about the different electives that are offered?

[00:42:34.74] DANIELA DRAGO: Mm-hmm. Besides the Summer Institute, which is the blended course that we have where students come to Washington, DC, we also have electives that are fully online. Some of them are, for example, more towards clinical research and some type of specific clinical design.

[00:43:01.75] We also have electives in health care quality. I think a full list is on the website. And then typically what happens is that after the first year, when the students are already more acquainted with what they want to get more detailed information, then that is a conversation with the academic advisors to pick the best elective for that specific student.

[00:43:37.42] JENNIFER KELLNER: OK, thank you. We have another question regarding to the background that you’re looking for to admit someone into the program. The student is asking if being a laboratory technician would be sufficient prior experience to translate into the regulatory affairs field.

[00:43:55.69] DANIELA DRAGO: Yes, we do have very many people that have– with an MLS background, for example, that then transition to the Regulatory Affairs program, and they’ve been very successful. So those are very good backgrounds too, yes.

[00:44:16.87] JENNIFER KELLNER: OK, thank you. We have another question about whether or not companies care if your master’s degree is online or on campus in terms of jobs. I can pretty much take that one if you want, Dr. Drago. Our degree, once you receive it, will not say anything about online. So there’s really no difference. It’s the same program on campus as it would be online. So there’s really no distinction there. Dr. Drago, do you have anything to add?

[00:44:45.67] DANIELA DRAGO: No, I agree with you, Jennifer. Absolutely, I would have said the same thing.

[00:44:50.27] JENNIFER KELLNER: Perfect. We have another question asking how much time each course takes for online graduates.

[00:45:00.61] DANIELA DRAGO: Yes. So our curriculum is pretty rigorous, which on the flip side means that you will learn a lot, but you also need to invest a lot. And typically, students allocate between 13 and 15 hours a week to be successful in a course. But imagine also that that type of work then gives you, also, the skills that allow you to be then a great candidate for a job. It doesn’t come easy.

[00:45:43.99] JENNIFER KELLNER: Definitely. Can you talk a little bit more about what sort of– what sort of jobs you see students getting into initially, right out of the program?

[00:46:03.14] DANIELA DRAGO: You know, it’s really hard to address this question– I think we had a similar question before– because it depends on what jobs they had when they entered the program. So I can tell you, for example, somebody that now is a recent graduate, and he actually even started to a guest lecture for us at GW.

[00:46:23.21] When he first started, he entered the program, and he was in a senior director position in a mid-sized pharmaceutical company, but he did not have a master’s degree. So he already had more than 15 years of experience in the regulatory, but to get to the next level, he needed to earn his master.

[00:46:45.66] So this person, obviously, is very different than someone that maybe has an MLS degree, only a couple of years of experience in the lab, and then wants to move from that lab position to maybe a chemistry manufacturing control regulatory specialist position once he or she was finished with the master. So it really depends.

[00:47:13.91] JENNIFER KELLNER: Thank you. And can you talk a little bit about group projects, and if they exist, and how that works with an online setting?

[00:47:22.37] DANIELA DRAGO: Yes, we do have group projects. Not every course has group projects, and also we hear from students, some students love it and some students less. So we try to accommodate, but nowadays, technology is really important and facilitates this. And regulatory is really one of these profession where you work a lot with others. And often, in reality, you work with others remotely. So we try to simulate the same situation that you would have in real life.

[00:48:02.14] JENNIFER KELLNER: Thank you, Dr. Drago. We have another question about the Summer Institute. Could you elaborate a little bit more on that?

[00:48:10.38] DANIELA DRAGO: Sure. Is something specific, Jennifer, or more than I just said? What would you like me to address?

[00:48:20.33] JENNIFER KELLNER: I think they’re curious about how that works, if that counts as like an elective or how that fits in with the general program.

[00:48:28.79] DANIELA DRAGO: Yes. So it counts as an elective, and it can be taken for credit. We also offer it as a conference. So some candidates, what they like to do is to come to the Summer Institute, attend it only as the conference, without getting any academic credit for it. It’s possible to do it so that they get to know their organizations and how we work. And I can probably say that 100% of those that did so then became students in the program.

[00:49:09.00] JENNIFER KELLNER: Very good. We have another question about whether or not there’s any time off during the program. Dr. Drago, do you want to talk about the scheduling?

[00:49:18.92] DANIELA DRAGO: Oh, can you take that, Jennifer?

[00:49:21.22] JENNIFER KELLNER: Sure, not a problem. So basically, the way it’s set up, if you’re doing the master’s program, you’ll have two 8-week classes back to back. And then we do give you a week break in between each semester. So every 16 weeks, you’ll have a week off. And then you also get things like Christmas break. So you still get a life, and certainly, as Dr. Drago mentioned earlier, it’s only 15 to 20 hours per week, so certainly lots of opportunity for good work-life balance as well.

[00:49:54.60] OK, any other questions out there? This time we’ll give you guys about another minute or so if you have any additional questions. And then, Dr. Drago, I’ll turn it over to you for final thoughts. OK, that seems to be all of our questions. If anybody has additional questions, please feel free to reach out to us here in admissions. All of our information is here. 844-386-7323 is our main line.

[00:50:41.54] Or you can email the general box at admissions@healt hsciencesprogram s.online.gwu.edu. And then the website there is also below. Dr. Drago, any final thoughts?

[00:50:56.96] DANIELA DRAGO: Thank you so much, Jennifer. And thank you everyone for joining us tonight.

[00:51:03.38] JENNIFER KELLNER: Thank you, everybody. And yes, this session is recorded and will be emailed to you guys all within about 24 to 48 hours or so. So you can certainly revisit it as much as you would like. And feel free to reach out to us with any specific questions. Thank you, again, everybody, and have a great week.

[00:51:25.39] DANIELA DRAGO: Bye.