Establishing and maintaining good relationships with regulatory agencies is important. Demonstrate competence, honesty, and respect in all communications. Be familiar with each agency's priorities and requirements. Address issues promptly and fully correct problems rather than just the specific instance identified. Strive for win-win solutions through logical, science-based arguments. Pick battles carefully and maintain a good compliance record over time. Avoid hostility and respect all agency employees.
FDA Enforcement & Compliance for Medical DevicesMichael Swit
Presentation to the Food & Drug Law Institute (FDLI) Introduction to Medical Device Law, with a focus on:
* FDA Jurisdiction to Enforce
* Prohibited Acts and Penalties
* Inspections – FDA’s Prime Enforcement Tool
* Other “Cops on the Beat”
* Commissioner Hamburg’s Enforcement Initiative
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
How to prepare and handle a FDA Inspection. When the FDA conducts an audit of your company, you need to be prepared. This presentation shows you what to do when your are faced with a FDA Inspection. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-inspection/
FDA Enforcement & Compliance for Medical DevicesMichael Swit
Presentation to the Food & Drug Law Institute (FDLI) Introduction to Medical Device Law, with a focus on:
* FDA Jurisdiction to Enforce
* Prohibited Acts and Penalties
* Inspections – FDA’s Prime Enforcement Tool
* Other “Cops on the Beat”
* Commissioner Hamburg’s Enforcement Initiative
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
How to prepare and handle a FDA Inspection. When the FDA conducts an audit of your company, you need to be prepared. This presentation shows you what to do when your are faced with a FDA Inspection. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-inspection/
Regulatory Considerations in Product DevelopmentMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in November 2011 on how to develop FDA-regulated products, with a focus on planning, working with FDA,
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
Drug Regulatory Affairs By Mr. Pankaj DhapadePankaj Dhapade
This presentation covers basic understandings of regulatory affairs profession. It contains,
1. Introduction of Regulatory Affairs
2. Why Drug Regulatory Affairs
3. Role of Regulatory Affairs Experts
4. Qualities of Regulatory Affairs Expert
5. Qualities for Submission Management
6. Regulatory Bodies
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
Marketing, Advertising and Promotion of Pharmaceuticals and Medical DevicesGlobalCompliancePanel
The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA").
FDA Enforcement: The Cop is Back – How Enhanced Enforcement Can Impact You a...Michael Swit
December 15, 2010 webinar sponsored by The Weinberg Group on increased FDA enforcement activity under the Obama administration, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
Key FDA Enforcement Actions
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA’s Record under Enhanced Compliance
FDA Enforcement – Trends, Powers and Penalties Or “Why Crime Does Not Pay”Michael Swit
June 12, 2009 presentation to the Southern California Biomedical Council on FDA enforcement, with a focus on:
FDA Regulatory/Enforcement Authority --
Understanding
FDA Enforcement Trends
Drugs
Devices
Clinical Trials
Collateral Consequences of FDA Violations
Presentation made by Ilyssa Levins at NYU on October 5, 2011 to the Master's Program class of "Public Relations Specialties," taught by PR veteran Saralie Slonsky.
In the 35 slides included here, Ilyssa describes her career path and the industry itself.
She founded her company, Center for Communication Compliance, in 2008 which offers pharmaceutical and medical device companies training and certifications in regulatory compliance.
www.communicationcompliance.com
For more information and specific PR case histories, contact Ilyssa at ilevins@communicationcompliance.com
Class Description: http://www.scps.nyu.edu/course-detail/PRCC1-GC2220/20113/public-relations-specialties
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
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5cl-adba precursor (semi finished )
5cl-adba raw materials
ADBB precursor (semi finished )
ADBB raw materials
APVP powder
5fadb/4f-adb
Jwh018 / Jwh210
Eutylone crystal
Protonitazene (hydrochloride) CAS: 119276-01-6
Flubrotizolam CAS: 57801-95-3
Metonitazene CAS: 14680-51-4
Payment terms: Western Union,MoneyGram,Bitcoin or USDT.
Deliver Time: Usually 7-15days
Shipping method: FedEx, TNT, DHL,UPS etc.Our deliveries are 100% safe, fast, reliable and discreet.
Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details.
We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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Collateral Consequences of FDA Violations
Presentation made by Ilyssa Levins at NYU on October 5, 2011 to the Master's Program class of "Public Relations Specialties," taught by PR veteran Saralie Slonsky.
In the 35 slides included here, Ilyssa describes her career path and the industry itself.
She founded her company, Center for Communication Compliance, in 2008 which offers pharmaceutical and medical device companies training and certifications in regulatory compliance.
www.communicationcompliance.com
For more information and specific PR case histories, contact Ilyssa at ilevins@communicationcompliance.com
Class Description: http://www.scps.nyu.edu/course-detail/PRCC1-GC2220/20113/public-relations-specialties
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HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
Contact us if you are interested:
Email / Skype : kefaya1771@gmail.com
Threema: PXHY5PDH
New BATCH Ku !!! MUCH IN DEMAND FAST SALE EVERY BATCH HAPPY GOOD EFFECT BIG BATCH !
Contact me on Threema or skype to start big business!!
Hot-sale products:
NEW HOT EUTYLONE WHITE CRYSTAL!!
5cl-adba precursor (semi finished )
5cl-adba raw materials
ADBB precursor (semi finished )
ADBB raw materials
APVP powder
5fadb/4f-adb
Jwh018 / Jwh210
Eutylone crystal
Protonitazene (hydrochloride) CAS: 119276-01-6
Flubrotizolam CAS: 57801-95-3
Metonitazene CAS: 14680-51-4
Payment terms: Western Union,MoneyGram,Bitcoin or USDT.
Deliver Time: Usually 7-15days
Shipping method: FedEx, TNT, DHL,UPS etc.Our deliveries are 100% safe, fast, reliable and discreet.
Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details.
We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
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In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
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The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
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Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
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O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
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How to establish and maintain a great working (3))
1. How to Establish and Maintain a GoodHow to Establish and Maintain a Good
Working Relationship with allWorking Relationship with all
Regulatory AgenciesRegulatory Agencies
Jerome J. Gainer, ASQ Certified GMP
Pharmaceutical Professional and
ASQ Certified Quality Engineer
Originally Presented at
Pet Industry Advisory National Forum Series
By
2. Which of these quotes shouldWhich of these quotes should
describe your attitude concerningdescribe your attitude concerning
Regulators and Regulations?Regulators and Regulations?
“A civil servant [in a regulatory agency] is like a broken
cannon. It won’t work and you can’t fire it.”
—George S. Patton
OR
“It is bad policy to regulate everything where things may
better regulate themselves and can be promoted by private
exertion, but it is no less bad policy to let those things
alone which can only be promoted by interfering social
power.”
—Friedrich List
3. What is the ultimate authorityWhat is the ultimate authority
for Animal Healthfor Animal Health
Regulations?Regulations?
“Let us make man in our image, in our likeness,
and let them rule over the fish of the sea, and the
birds of the air, over livestock over all the earth,
and over all the creatures that move along the
ground.”
–God
4. Is It Important to Have GoodIs It Important to Have Good
Relationships with these Agencies?Relationships with these Agencies?
Striving for a great relationship with all regulators should
be viewed as a top priority.
Good relationships with all regulatory agencies will avoid
the following:
Interruption in profitable activities to satisfy an
agency
Delays in approval of new products
Failure to achieve approval of new products
Market withdrawals for registration issues
Recalls, lost of reputation for quality
Loss of market share, devaluation of stock price
Failure to meet company goals, loss of bonus
opportunity
5. How Do You Know When YourHow Do You Know When Your
Company Has Achieved GreatCompany Has Achieved Great
Regulator Relationships?Regulator Relationships?
Goals and progress toward goals requiring regulatory
agency assistance or approval are being met.
Your requests to agencies (such as more time to respond)
are being granted.
Without prompting, agency offers to assist you.
Company is fully compliant with regulatory requirements.
6. Regulatory Agencies We Deal with inRegulatory Agencies We Deal with in
Animal HealthAnimal Health
Center for Veterinary Medicine (part of FDA)
US Federal Trade Commission
US EPA (Environmental Protection Agency)
USPTO (Patent and Trademark Office)
DEA (Drug Enforcement Agency)
VDD (Canadian equivalent of CVM)
MHRA (English equivalent of FDA)
Your state food and drug agency
7. Regulatory Agencies in AnimalRegulatory Agencies in Animal
HealthHealth
Your state board of pharmacy
Local city environmental agencies
Office quebecois de la langue francaise (Quebec language
police)
Various industry groups such as AAFCO and National
Animal Supplement Council
8. What Specifics Do I Need to KnowWhat Specifics Do I Need to Know
about Each Agency?about Each Agency?
What are this agency’s “hot button” issues?
What power/affect can they have on my business?
What reoccurring submissions/documents must be
prepared?
What routine/extraordinary cost can I expect?
What level of trust have I built with this agency?
How can I get a yes to my request/submission?
How can I stay off of their problems list?
9. Hot Button IssuesHot Button Issues
Center for Veterinary Medicine
Recalls
Illegal advertising and promotion
Misbranded labels
Unprofessional new drug applications
10. Hot Button IssuesHot Button Issues
Center for Veterinary Medicine
Quality system failures in GMP inspections (483’s)
Failure to submit post approval documents (MCSR)
Disrespect of agency employees
Outright fraud
11. Hot Button IssuesHot Button Issues
Environmental Protection Agency
Failure to submit Quarterly Pharmacovilgilence
EPA report on quantity of pesticide manufactured
Changes to EPA approved labels
Failure to respond to Data Call-in Request
12. Hot Button IssuesHot Button Issues
Environmental Protection Agency
Failure to follow up on PR notices
Failure to register a plant that makes any part of a
FIFRA product
Performing EPA testing in non GLP facility
Making changes to Confidential Statement of
Formula
13. Hot Button IssuesHot Button Issues
Veterinary Drug Directorate (Canada CVM)
Not maintaining GMP compliance of US
manufacturing site (Not able to register facility)
Unacceptable French Language translation
Failure to establish a QA release operations on
Canadian soil (for DIN products)
Importance of documents (as VDD audit will be be
conducted in Canada even if plant is in USA)
Preparing a thorough Site Master File
Import issues
14. Hot Button IssuesHot Button Issues
MHRA (English equivalent of FDA)
Poor outcome of on site inspection concerning:
– Facilities
– Changes
– Quality Issues (critical deficiencies)
Poorly prepared site master file
Inaccurate/late compliance report (questionnaire)
Batch to batch variations
Failure to submit updates
Failure to follow up on previous deficiencies
15. Hot Button IssuesHot Button Issues
State Boards of Pharmacy
License required for manufacturer/distributor of
prescription animal drugs
Inspection of the manufacturing/distribution site for
– General Sanitation
– Temperature history in storage area vs label
– Expiration date of drugs
– DEA security
– Invoice matching
– Overall security of site and drugs from
pilfering/theft
16. Things to Do to Establish/MaintainThings to Do to Establish/Maintain
Great Regulator RelationshipsGreat Regulator Relationships
Demonstrate competence in verbal and written
communications.
Provide supporting documentation for any claims.
Strive to be clear, scientifically justifiable, logical, and
well organized in written communication.
Take advantage of meeting regulators at stakeholder
meetings and other venues.
17. Things to Do to Establish/MaintainThings to Do to Establish/Maintain
Great Regulator RelationshipsGreat Regulator Relationships
Demonstrate familiarity with challenges that your
regulator may have when speaking with them.
Respect and utilize the expertise of your regulator when
needed.
Be honest in all your documentation, and do not try to hide
obvious problems. Instead show them how you propose to/
or have corrected the problem.
Express appreciation and respect to regulators for help
they give.
18. Things to Do to Establish/MaintainThings to Do to Establish/Maintain
Great Regulator RelationshipsGreat Regulator Relationships
Be holistic in correcting a problem. Do not just correct the
one instance that the regulator pointed out to you.
Become familiar with guidance documents.
Clarify the regulators question before you try to answer it.
Give full, complete and truthful responses to the exact
question that is asked.
Keep an accurate and complete record of communications
with regulators.
19. Things to Do to Maintain GreatThings to Do to Maintain Great
Regulator RelationshipsRegulator Relationships
Pick your battles carefully.
Do recognize that although guidance and statues may
appear to be written in stone, good science and logic can
prevail.
Maintain a good record with regulators.
– Respond by due dates or request more time.
– Provide quality professional work.
Strive for win/win solutions.
Clear up misunderstandings and summarize discussions.
20. Things Not to Do to Maintain GreatThings Not to Do to Maintain Great
Regulator RelationshipsRegulator Relationships
Don’t refer to regulators as just “bureaucrats” or provoke
them with hostile comments.
Don’t provoke regulators in written communications by
offensives words, unnecessary bolding or capitalization.
Don’t disrespect agency employees regardless of race,
gender, or religion.
Don’t be afraid to ask for what you want—but try to
supply them with logical, scientifically based reasons why
they should agree.
21. How to Establish and Maintain aHow to Establish and Maintain a
Great Working Relationship with AllGreat Working Relationship with All
Regulatory AgenciesRegulatory Agencies
Questions?
Questions?
Questions?