How to prepare for COMP360 approval | November 2026
Dear Subscriber,
The field is still waiting on the FDA, but the people building it are already planning for the workforce they’ll need. In this issue, Elizabeth explains why training that keeps its quality as it grows has become a shared priority for everyone from drug developers to practicing clinicians. If you’ve been thinking about getting ready for what’s ahead, this is the month to act: pre-registration for our Post-Approval COMP360 Psilocybin Certificate Program and the final call for our November 30th Essentials session are both inside.
- Founder’s Corner: A Shared Standard for the Psychedelic Workforce
- Pre-register for the Post-Approval COMP360 Psilocybin Certificate Program Now: Final Chance to Enroll Early
- Final Call to Register for the November 30th Accelerated Session of Essentials of Psychedelic Therapy
- Upcoming Event: Psychedelic Lived Experiences Summit 2026
- Recent Updates in the Psychedelic Therapy Space
Happy reading!
A few weeks ago, a board member of a late-stage pharmaceutical company with a psychedelic treatment close to approval asked me a pointed question. When a training program grows to serve many clinicians across many sites, how do you know the people completing it can actually do the work?
Not long after, I had the opportunity to explain our process to clinicians leading established and reputable ketamine therapy practices. They are planning to add psilocybin therapy to their practice if and when it is approved by the FDA, and they wanted to understand how Fluence would prepare their clinical teams. As I walked them through it, I realized I was answering the same question I had been asked by the board member.
One question came from the leadership of a company working to bring a treatment to market. The other came from clinicians who will deliver that treatment to their own patients. Fluence uses current technology to make training available to clinicians at scale, and both wanted to know how oversight and quality of that training is maintained at scale. They were asking for the same thing: training that keeps its quality as it grows. That overlap has stayed with me, and it is what I want to write about this month.
A month of conversations across the field
October was a month of conversations for me, and they continue this week at CNS Summit in Boston. I have spoken with leadership at a late-stage psychedelic drug developer, founders of clinical care delivery organizations, and leaders of federal-level mental health advocacy organizations. I have talked with biotech startup co-founders whose companies were successfully acquired by large pharmaceutical companies, with research study clinicians, and with study participants who have experienced this kind of treatment firsthand. I have met with representatives of contract research organizations (CROs) who are working on the next wave of international Phase 3 trials. And the entire Fluence team has continued working with our existing partners, who are rolling out studies spanning depression, PTSD, anxiety, and other indications across North and South America, Europe, and Asia, with a shared goal of improving data quality and integrity.
These people sit in very different places in this field, and they answer to different pressures. A drug developer is accountable to regulators and investors. A care delivery organization is accountable to its patients and its clinicians. A CRO is accountable for whether data from dozens of sites can be trusted. An advocate is accountable to the communities they represent. Study clinicians and participants know firsthand what it is like to be in the room.
What everyone is asking for
When I talk with all of these people about workforce training, three things stand out to me as shared priorities. The first is skill in the relational aspects of care. During a psychedelic dosing session, a person may spend many hours in intense and unfamiliar states, and the clinician’s steadiness, attunement, and ability to hold appropriate boundaries shape how safe that person feels. Across my conversations, people spoke about the therapeutic relationship as part of what makes these treatments safe and effective. They want clinicians who can be present with someone in a vulnerable state and who know how to respond when an experience becomes difficult.
The second is competence in safety monitoring and adverse event reporting. I wrote earlier this year about the FDA’s final guidance on psychedelic clinical investigations, which asks site teams to document a wide range of effects carefully and consistently. In an international Phase 3 program running across many sites, countries, and languages, small differences in how staff recognize and record what they observe can add up to a real problem for data integrity. Ultimately, that becomes a problem for the patients who will rely on the evidence those trials produce. The CRO representatives and research partners I spoke with returned to this point again and again.
The third is training that is accessible and efficient while still building and certifying nuanced skills. Practicing clinicians cannot step away from their caseloads for months at a time. Research sites need to train new staff as teams change over the course of a long study. Care delivery organizations need to prepare clinicians across multiple locations to a consistent standard. At the same time, the skills involved, such as holding neutrality, responding to a participant in distress, and knowing when to escalate a safety concern, are developed through practice, feedback, and assessment over time. Leaders want both accessibility and depth, and they are right to want both.
Nobody wants a checkbox
From the top of pharmaceutical companies to the patients in the room, no one wants a certification program that only involves clicking through slides and checking a box. I heard this from every group I spoke with. Box-checking is appealing because it is easy to scale and easy to document, and a completion certificate shows that a clinician has viewed the material. It shows very little about how that clinician will respond four hours into a session when a participant becomes frightened, or whether they will recognize and accurately report an adverse event.
This brings me back to the question about human oversight. At Fluence, technology carries the parts of training it does well: delivering consistent content to learners wherever they are, giving clinicians room to practice at a pace that fits their working lives, and tracking progress across sites and regions. Experienced clinicians remain responsible for the parts that require judgment, including reviewing how learners practice core skills, offering feedback, and determining whether someone has demonstrated the competence the work requires.
We have built this approach through extensive work in partnership with research and clinical care organizations, and it continues to be shaped by what sites and clinicians tell us is working and what is not. For the leaders of the ketamine practice, the questions were practical: how would their clinicians be supported and evaluated? Clinicians and practice leaders who will be accountable to patients deserve a clear answer about what their certification means.
What this means for you now
If you are a clinician waiting for approvals, I want to say plainly that the preparation you do now matters. The people I have spoken with are planning for a workforce with exactly these skills, and the clinicians who build those foundations during this period will be well placed when opportunities open, whether through research participation, continuing education, or new roles in clinical care.
This topic is close to our own work. Fluence is preparing to launch a healthcare provider training for the future delivery of COMP360*, an investigational psilocybin treatment, to meet the field’s need for training designed to support safe and consistent treatment administration at scale in the event of FDA approval. We are planning to open enrollment on November 30. Pre-registration for Fluence’s Post-Approval COMP360 Psilocybin Certificate Program is open now, so you can secure your spot before the program launches.
Where this leaves us
We are all still waiting for news from the FDA regarding psilocybin and MDMA. We are following developments closely and will continue sharing the news most relevant to clinicians through this newsletter and our social media accounts as it is announced. What I can say, after a month of these conversations, is that the people building this field agree more than I expected on what clinicians need, and they are already planning around it. The preparation happening now, in training and in partnerships across research and clinical care, is what will determine how well patients are served once approvals arrive.
Thanks for reading,
Elizabeth Nielson, PhD
Co-Founder & CEO
*Disclosure: Fluence is one of five organizations awarded a grant through Compass Pathways’ U.S. healthcare provider training grant program, which partially funds the development of a training program for sites of care delivering psychedelic treatments, including a module specific to COMP360. Fluence develops this program independently and retains final approval over its content, faculty selection, and educational design.
Pre-registration for Fluence's Post-Approval COMP360 Psilocybin Certificate Program is open until November 30th. Reserving your seat means you'll be first in line for enrollment, certification, and every update as the curriculum comes together.
Start dates for the first two courses in the program are now set:
January 4, 2027
February 1, 2027
March 1, 2027
Reserve your seat with a $500 deposit. Your deposit locks in the introductory program price before general enrollment opens at the end of the month. The deposit will apply to whichever start date works best for you, once general enrollment opens.
Enrolling a Group?
Fluence helps clinics and group practices build and maintain a consistently trained clinical team as your services evolve, without coordinating it alone. Bulk enrollment support pairs with Fluence Sync, our proprietary platform for tracking trainee progress, readiness, and audit-ready reporting. It's how we help you inform your protocols and build consistent clinical competency across your team with high-quality, practitioner-led training. For detailed information on how Fluence can support your clinic or group practice as you integrate COMP360 into your business, schedule a consultation here: http://meetings.hubspot.com/kcooppan-boyd
Have you taken foundational coursework already?
If you've completed comparable training, you can test out of Course 1 (Foundations of Psychedelic Care) by passing a live competency assessment, and Course 2 (Understanding Psilocybin) by passing a quiz. You're eligible if either of these applies to you, counting back from the date you apply:
A: You completed a qualifying training program in the last 2 years.
B: You completed a qualifying training program in the last 5 years and you were the primary clinician supporting at least 5 qualifying dosing sessions in the last 2 years.
Scheduling for the test-out process will begin November 30th. Your pre-registration deposit will apply towards Course 3 in the program and guarantee you a spot in one of the first cohorts. Fluence doesn’t determine which outside programs qualify. You’re responsible for deciding whether your prior training meets the course content as it is described on our website.
Curious about additional training opportunities beyond COMP360? Start your journey now and move toward certification in Ketamine-Assisted Psychotherapy or Psychedelic Harm Reduction and Integration at the current, lower rate. This November session is an accelerated version of the course, running 3 weeks rather than 6, with bi-weekly live Zoom sessions.
All certificate programs start with our six-week Essentials of Psychedelic Therapy course, with the November accelerated session taught by Sarah Zoghbi, LPC
Psychedelic Harm Reduction and Integration Therapy
Nov 30 - March 31, 2027
Ketamine-Assisted Psychotherapy
Nov 30 - April 13, 2026
All Fluence alumni who have taken a live-online course are eligible to join our 1200+ person Google Group. Members can work through protocol questions, share what they are seeing in the field, and get perspectives from colleagues doing the same work. If you have taken a live-online course but have not received your invite to the group, reach out here: [email protected].
Fluence Trainer Chantelle Thomas, PhD, will join the online Psychedelic Lived Experiences Summit, which runs November 20 to 22. Last year the summit brought together more than 3,000 attendees from 74 countries. This year’s theme is “Beyond the Protocol,” with a focus on safety, real-world outcomes, and the unmet needs clients face after psychedelic treatment.
Dr. Thomas is a clinical psychologist and researcher who works on post-protocol safety and on trauma-focused, ethical psychedelic care. She will speak on the opening roundtable, “After the Protocol: Continuity, Stabilization, and Longer-Term Support,” on Friday, November 20 at 11 AM ET. The panel also includes Rosalind Watts, Pedram Dara, Allison Feduccia, and Caroline Lilley.
Passes include live sessions plus recordings. The Standard Pass is $79 through November 19 and $119 after that. Scholarship applications close November 4.
Registration and full schedule: https://psychedeliclivedexperiences.com/summit
ICER Opens a Cost-Effectiveness Review of Compass’s Psilocybin Therapy
The Institute for Clinical and Economic Review (ICER) has begun assessing COMP360, Compass Pathways’ synthetic psilocybin for treatment-resistant depression. ICER’s reviews carry weight with insurers when they decide on coverage and pricing. Public comments on the draft scope are due November 10, and a public panel vote is planned for May 2027.
Read now →
VA Has Picked 10 Sites to Offer Psychedelic Therapy After FDA Approval
At the Psychedelic Healthcare Forum in New York, a VA senior advisor said the agency has chosen ten treatment sites, mostly ones with past psychedelic trial experience, and would start treating veterans soon after approval. He also warned that “demand will exceed our ability to supply these therapies,” and that even reaching a few thousand patients in the first year would be hard.
Read now →
Psilocybin Rewires Stressed Brains More Strongly, and Separately From the “Trip”
A UC Santa Cruz mouse study in Nature Neuroscience found that psilocybin quickly formed new, lasting connections between neurons, with a larger effect in chronically stressed mice. These structural changes depended on a different receptor pathway than the hallucination-like behavior, which supports work on non-hallucinogenic drugs. The results come from mice and haven’t been tested in humans yet.
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