Nancy,
Thank you for the follow up and work you are doing in this area. Please see below for a collection of questions that may be applicable to fostering "good thinking" skills for regulatory professionals. I hope the questions provide clarity on the goals for those sessions and might be useful as you and your team consider content. Please note that examples are shared in the first person because anything in the list below is something I am still working on and feel like I am far from doing well.
Cheers, Andrew Hadd.
1. Am I learning to think strategically and for the long-term?
This regulatory affairs role has a wonderful mixture of short-term problem resolution and long-term strategy and implications thinking. The RAPS session, "Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies" that Carla Wiese, Edward Black, and Vincent Legay hosted in June 2020 has a great mixture of combining current activities with effective outcomes. Being able to link our understanding of regulatory requirements with these practical applications is important.
2. Am I falling for a narrative fallacy instead of examining the supporting evidence?The products of our companies have tremendous potential to impact human health. Herein it has become important for me to make sure I am following the argument well and asking good questions about purpose and assumptions. Nassim Talib, in his book The Black Swan: The Impact of the Highly Improbable, suggests that "the narrative fallacy is associated with our vulnerability to overinterpretation and our predilection for compact stories over raw truths...the narrative fallacy severely distorts our mental representation of the world." Developing habits of asking good questions can start to address my own biases in a situation. I hope through that process to improve my tendency to buy into a narrative without considering the supporting evidence for it.
3. Am I buying into an assertion or an argument?I can find it easy to accept certain assertions and need to take time to understand what information could be missing, what else might be needed to support a particular intended use or how could an outside regulatory authority evaluate the same data. Developing this habit and ability to stay objective is challenging for me. For this, I am so grateful that I have a great place to work and an amazing team in our regulatory affairs department. We've created time in our week to discuss issues and potential solutions. Their perspective (and among our colleagues in RAPS) is invaluable and something to foster in our roles.
4. Do I know the fundamentals?Edward Burger and Michael Starbird wrote an excellent book, The 5 Elements of Effective Thinking, in which they make a great case for the power of understanding the basics in any field. In one story they cite Tony Plog, an acclaimed trumpet player working with advanced students through difficult sections of their pieces. Tony brings them back to playing scales. This seems simplistic to the students until he plays them with a stunning finesse and resonant beauty. He later explained to his students that "mastering an efficient, nuanced performance of simple pieces allows one to play spectacularly difficult pieces with greater control and artistry." For my tendency to rely on intuition or assumed knowledge about a topic, going back to fundamentals can be essential for success and providing greater support to my company and projects.
5. Are we approaching the problem creatively?
We are often working with groups of people on complex tasks, short deadlines and large consequences for getting it wrong. John Maxwell's book, Thinking for a Change, has a great chapter on unleashing the power of creative thinking. In it he asks 7 questions that I have found useful in my own work and interacting with project teams:
- Why must it be done this way?
- What is the root problem?
- What are the underlying issues?
- What does it remind me of?
- What is the opposite?
- Why is it important?
- Who has a different perspective on this?
6. Am I embracing the lessons from reflective thinking?
This concept is from another chapter in Maxwell's book, Thinking for a Change, in which he provides a foundation for building habits on reflecting about the week, the month and the year. He has tools for taking notes and questions to consider after a meeting, conference or training session. I am not good at this yet but find if I can sneak in time to ask what went well, what didn't go so well and what can I learn from it, that I am getting better over time. Reflective thinking is quite powerful, and something easily overlooked.
7. Do I have a pilot's "pre-flight checklist" mentality?
We have tremendous responsibilities in RA and provide essential information to navigate the regulatory landscape and bring good products to market that benefit others. When I first started in the role I found myself addressing many different issues (like all of us). Further, I was getting involved in side-topics outside of my immediate responsibilities or over-committing to tasks. Kudos to Wolfgang Jani, a career- and life-coach I met when we lived in Budapest, for his advice. He helped me work out a "pre-flight" checklist to help manage my role and decision making. I printed out this version and taped it on my desk near my monitor:
- WHY IS THIS [email, task, project, etc] IMPORTANT?
- IS THIS MY JOB?
- DO I NEED TO REPLY TO THIS EMAIL? NOW?
- DO I UNDERSTAND MY ANSWER?
- IS MY ANSWER CONSISTENT WITH REGULATORY REQUIREMENTS?
- WHAT ELSE IS IMPORTANT TO KNOW BEFORE I ANSWER?
- AM I ALIGNED WITHIN REGULATORY AFFAIRS? WITH MY BOSS?
- WHO IS RESPONSIBLE FOR THIS TASK?
- WHO ELSE CAN DO THIS WORK?
- IF SOMEONE ELSE NEEDS TO DO THIS, HAVE I SPOKEN WITH THEM?
- IF I AGREE TO DO THIS, CAN I DELIVER? BY WHEN? HAVE I CLOSED OUT OTHER TASKS BEFORE COMMITTING?
8. Am I thinking relationally and personally?Relationships matter. People are important and bring to any meeting or discussion a vast history or personal perspective that influences the conversation and paths taken. It is hard work for me to see that sometimes and reminds me of a great quote from the book A Gentlemen in Moscow. "For that matter, what can a first impression tell us about anyone? Why, no more than a chord can tell us about Beethoven, or a brushstroke about Botticelli. By their very nature, human beings are so capricious, so complex, so delightfully contradictory that they deserve not only our consideration, but our reconsideration and our unwavering determination to withhold our opinion until we have engaged with then in every possible setting at every possible hour." Therefore, taking time to get to know others can make a huge impact in the quality of our work and roles. To this end, I credit Leslie Cruz for instigating a "My Journey" exercise for our RA team. This involved sharing 3 to 5 slides about your career, family, interests and dreams. It was scary at first but has become a great point of connection for us and for any new people joining our team.
9. Do I have sustainable habits for sleep, exercise, good food and great friends?This may not be as directly related to thinking well but, according to Lisa Feldman Barret, a renowned neuroscientist and psychologist, "Literally, if there was only one thing you could do in your life, only one, it would be to sleep a decent amount every day [The Knowledge Project with Shane Parrish, Episode 92]." Without sleep, and I would add, exercise, eating well and setting aside time for friendships we are unable to live well much less able to do our jobs to the best of our abilities. We can overwork and shame sleep, and trust me, I tried to do so for too many years, but the short-term gains are completely not worth the long-term costs in health and relationships.
10. Am I growing spiritually? Do I see a bigger story and picture outside of myself and circumstances?My faith tradition, like many others, encourages set aside times to pray and read Scripture. I don't think I understood (understand) this habit as well but think that in our current culture, something that is quiet and draws us into a story much larger than we can imagine seems critical. Even if not for religious reasons per se but just 5 minutes of breathing exercises or going outside to stare at flower could make a huge difference in our lives, perspectives, care for others, humility, gratitude and joy.
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Andrew Hadd
Director of Regulatory Affairs
Austin TX
United States
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Original Message:
Sent: 19-Jan-2023 10:44
From: Nancy Singer
Subject: Skills needed by regulatory professionals
Andrew,
Thanks for taking the time to provide your ideas for the session on effective thinking that you believe should be included in the RAPS Certificate in Effective Communication. You have provided serveral good ideas and helpful resources. It would be great if we could learn even more details about your vision for the content of the program.Then we can find out if people are interested in attending the session. <o:p></o:p>
<o:p> </o:p>
Would you be willing to provide ten questions about the information that the session would cover? Then we can ask for additional ideas on the topic and whether the people in this discussion group believe there would be interest in the session.<o:p></o:p>
<o:p> </o:p>
Thanks again for your time and interest in helping educate our colleagues in the health care profession.<o:p></o:p>
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Nancy Singer JD, FRAPS, RAC
President, Compliance-Alliance
Newport Coast CA
United States
Original Message:
Sent: 17-Jan-2023 17:47
From: Andrew Hadd
Subject: Skills needed by regulatory professionals
Running effective meetings is already covered in the current course content but something to continue doing if not emphasize. Would you consider a course on effective thinking? Part of the course could be around the mental models regulatory affair professionals consistently use and how to understand, leverage, and communicate those to others. Another nuance of that course could be content emphasized in Five Elements of Effective Thinking by Edward Burger and Michael Starbird or creative thinking described in John Maxwell's Thinking for a Change. Increasing our ability to think well and to relate that knowledge to others is an important skill. Thanks for working on these courses and asking for input.
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Andrew Hadd
Director of Regulatory Affairs
Austin TX
United States
Original Message:
Sent: 17-Jan-2023 11:18
From: Nancy Singer
Subject: Skills needed by regulatory professionals
The courses in the RAPS Certificate in Effective Communications provide tips and techniques to improve RA professionals' soft skills.
I'm working with RAPS on these courses, and we want to make sure we're providing the most relevant information. It would be great if you would help us by letting us know what topics you believe should be included.
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Nancy Singer JD, FRAPS, RAC
President, Compliance-Alliance
Newport Coast CA
United States
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