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2

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CURRENT REGULATORY

CHALLENGES FOR PUBLICATIONS

ON DRUG SAFETY

Presented by

Mary H. Whitman, PhD

Senior Director, Medical Affairs

Janssen Biotech, Inc.

INTRODUCTIONS

• Faculty: Dr. Mary Whitman is currently Senior Director of Medical Affairs at Janssen

Biotech, Inc., Dr. Whitman oversees Phase IIIb and IV protocol development, regulatory

writing, and global publications andleads a full-service publication team of 13 full-time

medical writers at various careers levels. The team is responsible for publications based

on Phase I-IV clinical trials and numerous other data-driven publications.Since joining

Janssen (formerly Centocor) in 2002, the Publications Team has realized an annual

publication rate of approximately 60 publications in top-tier, peer-review biomedical

journals. During her 12-year tenure at Janssen, Dr. Whitman has received several

Johnson and Johnson Standards of Leadership Awards for Publication Excellence and

holds two Greenbelt Awards in Publications.

• Previously, Dr. Whitman served as Director of the Clinical and Statistical Analysis Team at

Covance Periapproval Services, Inc., where her role involved protocol design, business

acquisition, and the management and conduct of professional and regulatory writing and

publications.

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INTRODUCTIONS

• For approximately 25 years, Dr. Whitman has served as an active member of the American

Medical Writers Association. She is also an active member and/or currently serving on

committees of the Council of Science Editors, Society of Scholarly Publishing, ISMPP,

International Society of Pharmacoepidemiology, the Drug Information Association, and the

Regulatory Affairs Professional Society. For the last 10 years, Dr. Whitman has served on

the Board of Directors of Graduate School of Biomedical Sciences of Thomas Jefferson

University Alumni, and is now current President. In this capacity, she has acted as an

industry representative and has assisted in the design and teaching of courses tailored to

graduate students seeking a career in pharmaceuticals and career mentoring.

• Dr. Whitman holds a Doctoral degree in Biochemistry and Pharmacology from Thomas

Jefferson University in Philadelphia, Pennsylvania and a Master of Science Degree in

Toxicology from the University of Pittsburgh, Pittsburgh, Pennsylvania. Formal postdoctoral

research was conducted through fellowships awarded by the University of Maryland and

National Institutes of Health.

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INTRODUCTIONS

• Moderator: Lisa Baker is Principal Medical Writer and Team Lead at The

Envision Pharma Group, a publication planning agency. She received her

PhD in research psychology from McGill University and has been a medical

writer since 2006. Lisa’s work has included publication development and

strategic publication planning for varied clients and therapeutic areas. She

is an ISMPP Certified Medical Publication Professional™ (CMPP), a

member of the ISMPP-U committee and a former member of the ISMPP

Standards and Communications committees.

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DISCLAIMER

The information and opinions presented here reflect those of the

presenter and do not represent the position of Janssen Biotech or

the International Society of Medical Publication Professionals.

Presentation at this forum should be not construed as an

endorsement by any of these entities.

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OBJECTIVES

• To gain a better understanding of the regulatory framework and

obligation to publish safety data in light of the recent legislation (ie,

FDAAA and TEST ACT).

• To gain an understanding of the role that long-term safety studies and

registries will play in publications and the impact that recent legislation

has had on publications involving mandated post-approval studies.

• To acquire familiarity with the approach and challenges needed for

publishing safety and observational data including understanding of

the strengths and limitations for all stakeholders.

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TYPES OF TRIALS COLLECTING

SAFETY INFORMATION

• Randomized clinical trials (RCTs) – Studies of the efficacy and safety of a drug within a limited patient population, randomized

to study treatment for balance and comparability. Extensive inclusion and exclusion criteria are often applied, and patients are

followed for 1-2 year period of time to determine if prespecified study endpoints are achieved. The sample size for RCTs is often

on the order of a few hundred patients. Follow CONSORT www.consort-statement.org.

• Drug interaction studies – Studies evaluating the modified effect of a medicine when administered with another drug. The effect

may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated

with either medicine.

• Large simple trials (LSTs) – These studies include large numbers of people (typically several thousand) and extend over a long

period of time, typically many years, applying broad eligibility criteria with the intent to study the safety and/or efficacy of

treatments under "real world" conditions of use.

• Pharmacokinetic and pharmacodynamic studies– Pharmacokinetics (PK) measures processes such as drug absorption,

distribution, metabolism and excretion in living organisms.

• Safety studies – Studies determining incidence of adverse reactions. Phase 4 postmarketing studies may assess safety in larger

populations over broader timeframes, as compared to Phase 2 and Phase 3 studies.

• Completion of ongoing studies – Completion of clinical trials in progress at the time of regulatory approval may be required as a

postmarketing commitment.

• Safety Registries or other Postmarketing Commitments – “ mandated by health authorities… organized system that uses

observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by

a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose.” *

* R.E. Gliklich and N.A. Dreyer, Registries for Evaluating Patient Registries: A User’s Guide. Agency for Health Care Research and Quality.

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COMMON TYPES OF SAFETY

PUBLICATIONS

Safety Publications encompass:

• Part of the fair-balance safety data resulting from randomized clinical trials – reported with

efficacy data and health related outcomes

• Traditional open-label and other interventional LST studies that include both efficacy and

safety

• Long-term study extensions of their respective randomized clinical trials, generally planned

apriori during the premarketing stage

• Integrated data from clinical development programs

• Observational Postapproval Research Programs (often mandated by Health Authorities)

• Meta-analyses of safety based on available published literature during the post-

approval/postmarketing period

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TRANSITION TO FOOD AND DRUG

ADMINISTRATION AMENDMENT ACT

(FDAAA)

FDAAA signed into law in 2007 has since evolved into a number of policy initiatives:

Aimed at improving transparency and public knowledge of clinical trials

In 2008, a database was launched for reporting summary results from clinical trials via

a self-reported web-based system

US Public Law 110-85, Title 8 legislation passed into law amid concerns regarding:

• Ethical and scientific issues affecting design, conduct, and

reporting of clinical trials including suppression and selective

reporting of results based on sponsor’s commercial interests

• Alteration and omissions in reporting prespecified outcome

measures – especially drug and device safety

• “Off-shoring” human subjects of research

• Failure to report adverse and serious adverse events

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RISK-BENEFIT IN THE BALANCE

The Food and Drug

Administration Amendments Act

of 2007 gave FDA the authority to

require Risk Evaluation and

Mitigation Strategies (REMS)

from manufacturers to ensure

that the benefits of a drug or

biological product outweigh its

risks.

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RISK EVALUATION AND MINIMIZATION

• May be required preapproval based on a range of risk factors:

• Estimated size of the patient population

• Seriousness of disease or condition

• Expected benefit

• Duration of treatment

• Seriousness of known or potential adverse events

• Drug represents a new molecular entity or mode of action

• May be required postapproval only on the basis of new safety information

• Postapproval studies, adverse event reports, peer-reviewed literature, FDA postmarketing surveillance, and new

analyses of existing data.

• REMS Components include:

• Medication guide or Patient Package Insert

• Communication Plan

• Elements to assure safety use to address a specific known risk

• Timetable for Assessment

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FDAAA

• Prior to the FDAAA legislation of 2007, the International Committee of Medical Journal Editors (ICMJE) endorsed the public posting of clinical trial methodology as a condition for peer-review. Presently, more than 140,000 trials have been registered with locations in 182 countries.

• Approximately 330 new and 2000 revised registrations are submitted each week, but with 30 new and 80 revised results reporting.

• Full compliance with FDAAA would result in more than an estimated 100 newly-registered results per week – lagging and inadequate.

• Of those registered today, only about 15% are linked to a PubMed citation through an NCT Number.

• Large increase in number of clinical trials registered (>85%) on (www.clinicaltrials.gov) since the FDAAA Legislation but still woefully lacking.

• Major Focus is Safety!

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ASPECTS OF FDAAA

• FDAAA mandated posting of summary results within 12 months of

completion of primary and secondary endpoints after FDA approval of drugs,

biologics, and devices, irrespective of whether or not a publication exists.

• Imposes significant monetary, civil, and criminal penalties for noncompliance

(eventually).

• Posting results under FDAAA is not restricted to industry-sponsored trials

intended to support marketing applications and includes trials irrespective of

sponsorship.

• ClinicalTrials.gov conducts a full quality review of results and requests

updates that are tracked and accessible through a “History of Changes” link.

Results are displayed with the protocol elements of the original posting with

the unique NCT number.

• Resources to links, additional information, and PubMed citations are

inserted by the National Library of Medicine.

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FDAAA

Objectives

• Satisfy legal requirements

• Promote objective, standardized reporting by capturing key trial features in the form of tabular data while minimizing

potentially subjective narrative text

• Facilitate “good reporting practices”, including accommodation of publishing and regulatory guidelines

• Provides structured data entry to ensure complete reporting, efficient quality review, and consistent display of both

required and voluntary data elements

• Support detailed searches with the use of the database structure and other National Library of Medicine functions

Description of scientific modules (in tabular format)

• Participant flow: Progress of research participants through each stage of a trial according to group, including the

number of participants who dropped out of the clinical trial

• Baseline characteristics: Demographic and baseline data for the entire trial population and for each group

• Outcome measures and statistical analyses: Aggregate results data for each primary and secondary outcome

measure according to group; statistical analyses as appropriate

• Adverse events: List of all serious adverse events; list of other (not including serious) adverse events in each group

that exceed a frequency threshold of 5% within any group; both lists include adverse events, whether anticipated or

unanticipated, and grouped by organ system

Administrative information

• Key dates and contact information

• Description of agreements, if any, between the sponsor and the principal investigator that would restrict dissemination

of results by the principal investigator

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FDAAA TITLE IIIV, SUBTITLE A

• Postmarketing Studies and Clinical Trials

• Empowers FDA to require postapproval studies, clinical trials, and safety registries

• Labeling Authority

• The FDA can mandate expedited labeling changes and enforcements

• Risk Evaluation and Minimization Strategies (REMS)

• Strategy to manage a known or potential serious risk associated with a drug

• Empowers the FDA to require the sponsor to execute REMS, if necessary, to ensure the

benefits of the drug outweigh the risks

• Can be required throughout the product lifecycle

• Enforcement

• To prevent misbranding and impose substantial civil monetary penalties for violations related to

REMS and other Postmarketing Safety Requirements

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ICMJE STILL IN CONFLICT BUT PASSIVE

COMPLIANCE WITH FDAAA

“The ICMJE does not consider results posted in clinical trial registries as previous

publication if the results are presented in the same, ICMJE-accepted registry in which initial

registration of trial methods occurred and if the results are posted in the form of a brief

structured abstract or table. The ICMJE also believes that the results registry should either

cite full publications of the results when available or include a statement that indicates that

the results have not yet been published in a peer-reviewed journal.”

US Public Law 110-85 (FDAAA, Title VIII): Mandatory reporting for summary results

information including adverse events must occur no later than one year after the completion

date for registered trials for drugs that are approved.

19

ICMJE HAS NOT STRENGTHENED ITS

POSITION ON FDAAA COMPLIANCE

– “ICMJE believes that parties interested in results registration should

consider requiring the deposition of such an abstract in the registry 24

months after closure of data collection if the results have not published in

a peer-reviewed venue at that time (published in a Separate Statement,

June 2007).”

…basic results “include summary data tables of baseline characteristics,

participant flow, outcomes, and adverse events. With the exception of several

brief free-text fields for providing descriptions of the data, no narrative

information is included (e.g., there is no discussion or conclusion section).

There will be no patient level data.”

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DEFINITION OF “TRIAL”

UPDATED BY ICMJE

Old definition: any research that prospectively assigns human subjects to an intervention

to study the cause-and-effect relationship between a medical intervention and a health

outcome (PK, Phase I, and toxicity studies are exempt from registration).

Current definition: any research study that prospectively assigns human participants or

groups of humans to one or more health-related interventions to evaluate the effects on

health outcomes. (WHO definition under the New Clinical Trial Directive adopted by the

ICMJE, July 2008).

Health outcomes include any biomedical or health-related measures obtained in patients or

participants, including PK and adverse events.

Health-related interventions include drugs, surgical procedures, devices, behavioral treatments,

process-of-care changes, and the like.

Purely observational trials (those in which an intervention is not at the discretion of the investigator but

is prescribed according to usual clinical practice) will not require registration.

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FIELDS ON

WWW.CLINICALTRIALS.GOV

1. Unique identification.

2. Statement of intervention(s) and comparison(s) studied

3. Study hypothesis

4. Primary and secondary prespecified endpoints/outcomes

5. Eligibility criteria

6. Critical trial dates (e.g., start date, last patient visit date)

7. Target enrollment

8. Funding source

9. Contact Information for the principle investigator

10. Results? When? (ICJME: take your time but comply with minimal federal requirements)

What should be our obligation to disclose data, especially safety data?

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ICMJE’S POSITION ON THE FDAAA

REQUIREMENTS

“…disclosure will be a legal requirement, so there is nothing editors can do

about it if they still want to publish important trials of drugs and devices.

Moreover, journals will continue to add value by publishing useful and

readable trial reports that clinicians, the media, and patients can interpret and

use. And, most importantly, the results disclosed for the FDA will not have

been externally peer reviewed and will be preliminary. Peer review not

only provides a stamp of quality assurance, it often leads to reanalysis of

results.”

“…Editors should seriously consider for publication any carefully done study of

an important question, relevant to their readers, whether the results for the

primary or any additional outcomes are statistically significant. Failure to

submit or publish findings because of lack of statistical significance is an

important cause of publication bias.”

‘Uniform Requirements’

23

ICMJE’S POSITION

“It is important to note that the ICMJE requires registration of trial methodology but does not require registration of trial results; it recognizes the potential problems that could arise from the posting of research results that have not been subjected to an independent peer-review process. However, the ICMJE understands that the U.S. Food and Drug Administration Amendments Act of 2007 (FDAAA) does require researchers to register results. The ICMJE will not consider results to be previous publication if they are posted in the same primary clinical trial registry as the initial registration and if the results are posted in the tabular form dictated by the FDAAA. Researchers should be aware that editors of journals that follow the ICMJE recommendations may consider more detailed description of trial results and results published in registries other than the primary registry (in the case of FDAAA, ClinicalTrials.gov) to be prior publication. The ICMJE anticipates that the climate for results registration will change dramatically over coming years and the ICMJE may need to amend these recommendations as additional agencies institute other mandates related to results registration.”

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OBLIGATION TO PUBLISH ENDORSED

BY OTHER GUIDELINES

Various other guidelines relating to development and publication of biomedical literature are mentioned on ICJME’s website.

• COPE: Committee On Publication Ethics (www.publicationethics.org.uk)

- Forum for editors of peer-reviewed biomedical journals to discuss issues relating to ethics and integrity

- Membership represented by more than 5000 journals

- Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Patient Informed Consent, and the Declaration of Helsinki

• CONSORT Statement (Consolidated Standards of Reporting Trials); checklist; flow diagram www.consort-statement.org

• Library of Medicine on the ICMJE website: http://www.nlm.nih.gov/services/research_report_guide.html

• EQUATOR Network (International initiative for reporting health research studies) http://www.equator-network.org/home/

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GLOBAL STANDARDS

26

DIFFERING POLICIES PREVAIL

Source Registration Results Reporting

FDAAA* Interventional studies of drugs, Same as registration scope,

biologics, or devices (whether interventional studies (drugs,

or not approved for marketing); biologics, or devices) only

phases 2 through 4 after FDA approval for any use

ICMJE* Interventional studies of any Not required

intervention type, phase, or

geographic location

EMA* Interventional studies of drugs and Same as registration scope

biologics (whether or not approved

for marketing); phase 1 (pediatrics

only); phases 2 through 4; at least

one European Union site

*EMA denotes European Medicines Agency, FDAAA Food and Drug Administration

Amendments Act, ICMJE International Committee of Medical Journal Editors

27

TAXPAYER-FUNDED RESEARCH MUST BE POSTED!

What about publishing, as an ethical and a moral obligation, the results that tax-paying

patients, physicians, and US citizens supported with hard-earned dollars?

28

LACK OF CORPORATE COMPLIANCE

WITH FDAAA

• Through 2010, results for only 40% of the trials (34% of pivotal trials)

were eventually posted appeared even after more than 1 year

following study completion and loopholes in FDAAA made it possible

for sponsors not to register all trials.

• Too many loopholes in the law resulted in some sponsors not even

registering clinical trials much less reporting the results, thereby,

putting future participants at risk when another company develops a

drug of the same class or mechanism of action.

29

THE TRIAL AND EXPERIMENTAL

STUDIES TRANSPARENCY ACT

The TEST Act (August 2, 2012) expanded the registration and reporting requirements

establish by FDAAA:

• Register all interventional studies of drugs and devices, regardless of phase (including

Phase 1), design (i.e., including single group trials), or approval status (approved or

unapproved) before the first participant is enrolled.

• Strengthening the requirement to have results posted on www.clinicaltrials.gov within one

year of the completion of the trial irrespective of approval status.

• Requiring all foreign trials (rulemaking) that are used to support marketing in the US to

be registered and comply with the reporting requirements – 80% of drugs entering the

US market were clinically tested overseas but were not required to be registered.

• Providing for delayed submission of results (up to two years of trial completion) for

medical interventions that have never been approved for any indication.

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TEST ACT (CONTINUED)

• Expanded results pertaining to informed consent and protocol documents

• Requires results reporting whether or not an application is submitted to the

FDA for approval (e.g., novel therapeutic agents) so that adverse outcomes

would be posted even if abandoned by the manufacturer to alert others of

potential dangers and putative toxic effects that would necessitate monitoring.

• Improves transparency of clinical trial results – companies will be less able to

hide negative study results, safety signals, and adverse events.

31

TIME PROGRESSION FOR INCREASE

REGULATION

TEST ACT

2012

32

TEST ACT: WHAT ABOUT OUR OBLIGATION TO

PUBLISH IN PEER-REVIEW LITERATURE?

• The TEST ACT (August 2012) is mandating the basic results for all trials be

posted by 1 year after trial completion irrespective of approval status of the

drug or device.

• There is concern that the TEST ACT may actually increase rather than

decrease publication bias if sponsors feel less compelled to publish equivocal

trials because the basic results will already be in the public domain in a data

dump without interpretative value – time will tell.

• The time pressure and desired low visibility may result in more positive trials

being submitted quickly to journals and the negative trials being posted on

www.clinicaltrials.gov.

• If journals accept manuscripts after public posting, this may change the

importance of how publications are scored and affect acceptance rates.

Journals are reluctant to embrace full transparency.

33

HOW WILL THE TEST ACT IMPACT

SAFETY PUBLICATIONS?

• ICMJE’s Position?

• Peer-review?

• Publishability?

• Journal Publication of Medical and Pharmaceutical

Literature?

• With tabular format for adverse events posted on public

registers, of what benefit is posting to patients and the

medical community?

34

ICMJE

• Compliance with federal law is mandatory but acceptance of FDAAA and the TEST ACT is

not strong due to concern about compromised embargo and diminished newsworthiness.

Journals must change ideologically and be more accepting of safety articles. Safety data

should never be limited or embargoed.

• NEJM, a ICMJE member journal, endorsed the TEST Act (N Engl J Med 2012;367;9) but

stressed the continued use of simple tabular format for 3 tables: patient

enrollment/disposition, key primary and secondary outcomes, and adverse events. Tabular

format is not adequate to communicate safety to patients and physicians.

• Journals adhering to the Uniform Requirements (International Committee of Medical

Journal Editors) will not consider posting results to be pre-publication. However, journals

still demand oversight, impose limitations, and/or delay posting of results. Journals

accommodate what is minimally required by federal law.

• To date, the ICMJE website has not been updated to reflect the changes with the TEST

Act and does not strongly embrace FDAAA. Truly, the journals need to stress greater

compliance with posting results, especially those pertaining to safety.

35

DISCREPANCIES PREVAIL: POSTING AND

PUBLICATION ARE NOT ALIGNED ON FULL

TRANSPARENCY

• Peer-review is essential to oversight. Posting has no peer-review process and has no

interpretative value. Peer-review has been reserved for the journals. Why? So many

Laws and Rules yet none resulting in benefit to the patients and physicians.

• The ICMJE prohibits expounding on the results beyond a 500-word structured abstract,

and prohibits discussion and conclusions. Why?

• ICMJE does not include a provision for registering observational studies, and neither

FDAAA nor the TEST ACT require posting of non-interventional data, including data

from mandated safety registries. Why are these important studies exempt?

• Restricted results reporting by ICMJE and tabular formats render public registries (e.g.,

www.clinicaltrials.gov) data dumps or third-party repositories lacking analytical

interpretation and interpretative value. Why?

• Neither FDAAA or the TEST ACT address the compelling need to publish safety data in

peer-review journals. Why?

36

THE OBLIGATION TO PUBLISH

SAFETY DATA

• Peer-review publication of safety data must be an ethical obligation to be fulfilled by

pharmaceutical companies or any sponsor. Posting on public registers alone is not

adequate.

• Safety data, safety signals, and pharmacovigilence findings are not perceived as

interesting to publishers and journal editors but are vital to understanding the risk-

benefit of drugs and devices throughout the life-cycle of a product.

• Safety data from all sources should be both posted and published for complete

transparency and the benefit of patients.

• Observational as well as interventional safety studies should be posted whether or not

they are mandated by health authorities as well as published when adequate data

have been accrued and at the end of the commitment to answer critical questions or

verify signal detection.

• Safety registries due to their generalizability, by monitoring the safety of a product or

device in real-world clinical practice with minimal exclusion criteria, are increasingly

being mandated by health authorities globally. There is no requirement under FDAAA

or the TEST ACT to register or post the results let alone publish results.

37

PUBLISH ALL SAFETY DATA IN

PEER-REVIEW

• Observational data from mandated safety registry studies have a rough but

travelable road in peer-review journals.

• More journals are now willing to publish observational safety studies and data from

safety registries, especially those designed with some rigor (http://www.strobe-

statement.org/index.php?id=strobe-home).

• Transparency through peer-review publication of safety data is the right thing to do

even though it goes beyond the legally-imposed obligation met by posting.

• Safety data should be published irrespective of trial design or favorability.

• Safety data integrated from preapproval clinical development programs should be

published.

• Data from long-term safety extension studies from clinical trials should be published.

• All publications should represent fair-balance, embraced by benefit-risk and accurate

reporting with an explicit focus on patient safety.

38

EXAMPLE OF AN OBSERVATIONAL

SAFETY REGISTRY PUBLICATION:

TREAT SAFETY REGISTRY

39

EXAMPLE OF AN OBSERVATIONAL

SAFETY REGISTRY PUBLICATION:

PSOLAR SAFETY REGISTRY

40

EXAMPLE OF A LONG-TERM SAFETY WITH

INTEGRATED TRIAL DATA: PART I OVERALL

SAFETY

41

EXAMPLE OF A LONG-TERM SAFETY WITH

INTEGRATED TRIAL DATA: PART II TARGETED

SAFETY

42

EXAMPLE OF A SAFETY CASE REPORT

43

EXAMPLE OF AN INTEGRATED SAFETY

PUBLICATION

44

HOW TO BE REMEMBERED?

“If you would not be forgotten, as soon as you

are dead and rotten, either write things worth

the reading, or do things worth the writing.”

-Benjamin Franklin-

The First American Publisher

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THANK YOU

UPCOMING ISMPP U TOPICS

• Stay tuned for the upcoming ISMPP U topics

– The Sunshine Act: Wednesday, August 14th

– SPIRIT Guidelines: Tuesday, August 20th

48

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