Regulatory affairs
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Regulatory Affairs. Pat Ward November 1, 2011. Purpose. Regulatory Good-Standing…. Purpose. Protect…. Employees Students Patients Research subjects Neighbors Research Education Training Environment Fiscal steward- ship Integrity Reputation.

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Regulatory affairs

Regulatory Affairs

Pat Ward

November 1, 2011


Purpose

Purpose

  • Regulatory Good-Standing…


Purpose1

Purpose

  • Protect…

Employees

Students

Patients

Research

subjects

Neighbors

Research

Education

Training

Environment

Fiscal

steward-

ship

Integrity

Reputation


Products and services

Products and Services

  • In general…

    • Maintain awareness

      • Regulations and other standards

      • Stakeholder interests (faculty, staff, students)

    • Connect the dots between requirements and stakeholder interests

    • Fact-finding, advice, problem resolution

      • Remediation of misconduct, misbehavior, non-compliance

      • Faculty disputes over research resources

    • Chaperone interactions with regulatory authorities


Products and services1

Products and Services

  • OID and COI, in particular…

    • Operate Outside Interest Disclosure (OID) system (M-Inform)

      • Monitor external listings and resolve discrepancies

    • Review IRB and grant applications for Conflicts of Interest (COIs)

    • Negotiate, document, and monitor COI management plans (CMPs)

    • Support COI committees

      • MEDCOI, CECOIC, ICOI, OCs


Products and services2

Products and Services

Answer questions!

(or help find answers to them)


Customers

Customers

  • Internal

    • UMMS faculty, staff, students

    • Administrations at the UMMS division/department, center/institute, and school levels

    • UMHS Compliance, OVPR, and other central UM units

  • External

    • Oversight agencies

      • Government, accreditation, review boards


Customers1

Customers

Partners (making new ones every day!)

  • BTS/BEU

  • CC-CTO

  • CECOIC

  • Compliance Office

  • Compliance Committee

  • DRDA

  • eRRM

  • eRPM

  • Facilities

  • Finance

  • FGP

  • FOIA

  • GTMLP

  • HAL

  • HIM

  • HR

  • IBC

  • ICOI

  • IDS

  • IRB Council

  • IRBMED

  • MCRU

  • MEDCOI

  • MICHR

  • MSIS

  • OAA

  • OCA

  • OFA

  • OGC

  • OHRCR

  • OoR

  • OSEH

  • OTT

  • OVPR

  • PR&M

  • QA

  • Risk Management

  • RPC/RDRC/SHUR

  • TPS

  • U-Audits

  • UCUCA

  • ULAM


Staffing trends

Staffing Trends

  • 2008 – present

    2 FTE from OoR (General)

    + 3 FTE from Dean’s Office (OID/COI)

    5 FTE in new RA office

    - 1 FTE attrition

    4 FTE (late 2008 - early 2011)

    + 3 FTE (increase in requests for general assistance,

    7 FTE expansion of COI to clinical and educational

    areas, political/media attention to OIDs)


Current tactical initiatives

Current Tactical Initiatives

New COI Rules

  • Develop and implement plan by August 2012…

    • Review OIDs of every investigator on every PHS grant at submission

      • Not just PI, not just when COI “checked”, not just if awarded

    • Investigator OID must be current (within 30 days)

      • Not just annual

    • COIs must be managed and details reported to NIH (60 days)

      • Not just yes-or-no

    • Additional training, reporting, public release/posting of COIs, elaborate investigation and documentation of minor non-compliance


Current tactical initiatives1

Current Tactical Initiatives

Proposed IRB rules

  • Analyze and comment by October 26, 2011

    • Possible benefits

      • Better calibrate level of review to level of risk

      • Eliminate most annual reviews

      • Harmonize disparities in various similar regulations

    • Possible pitfalls

      • Expand regulations to de-identified data/specimens

      • Expand regulations to non-federally funded research

      • Require elaborate IT security and consent even for low risk studies


Current tactical initiatives2

Current Tactical Initiatives

Clinical and Educational COI

  • Recent policies

    • Industry funding of CME

    • Ghostwriting

    • Disclosure to students

  • Upcoming discussions

    • Promotional speaking

    • Consulting

    • Website for public disclosure of OIDs


Current tactical initiatives3

Current Tactical Initiatives

FDA Regulatory Survival

  • Noncompliance

    • What went wrong and how to fix it

  • Inspections

    • Preparing for and responding to

    • Monitoring CAPA plan compliance

  • Faculty holding IND/IDEs

    • Know what they’re getting into


Current tactical initiatives4

Current Tactical Initiatives

Misconduct or misbehavior

  • Investigations

    • Shorten TAT

    • Streamline steps and participants

    • Build investigative and assessment skills

    • Evidence chain-of-custody

    • Integrity of documentation


Current tactical initiatives5

Current Tactical Initiatives

Dry Ice Shipping


Opportunities for collaboration synergy

Opportunities for Collaboration & Synergy

  • RA improvement initiatives

    • Information management and tracking systems

    • Website renovation and high-priority messages

    • Outreach to internal stakeholders

    • Regulatory analysis

  • Synergies with UMMS units

    • Departmental liaisons

    • Work together to cover all angles (HR/FA, MICHR)

    • Sharing lessons learned (even painful ones!)


Regulatory affairs

Thank You


Appendix

Appendix


Organizational structure

Organizational Structure


Key performance indicators

Key Performance Indicators

  • OID/COI

    • % OID compliance

    • # CMPs produced/monitored

    • eResearch review TAT

  • General

    • # Regulatory interactions facilitated

    • # Noncompliance cases facilitated

    • # Repeat violations avoided


Benchmarked data and performance

Benchmarked Data and Performance

Comparing notes with peers at other institutions

  • University of Miami – FDA inspections

  • University of Minnesota – IND/IDE programs

  • MD Anderson – IND/IDE programs

  • Vanderbilt – Clinical data de-identification

  • Case Western – Clinical COI

  • Duke – International human research

  • Johns Hopkins – Human subject protection

  • Ohio State University – Animal management programs, new COI rule implementation

  • University of Pittsburgh – IND/IDE programs, COI systems, honest broker system

  • University of Wisconsin – Clinical trial registration

  • CTSA RKSP Leaders – IRB systems

  • University of California – Various regulatory concerns

  • University of Iowa – OID disclosure websites


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