MSL-BC Exam Cer fica on exam for medical science
liaisons via Medical Science Liaison Society. (MSL-BC)
WITH COMPLETE SOLUTION UPDATED NEW!! 2025/2026
100% VERIFIED CORRECT
PhRMA Code - Ans 1. voluntary code
2. last revised 2021
3. Ensure industry interac ons with HCPs are professional exchanges designed to benefit
pa ents and to enhance the prac ce of medicine
4. Based on the principle that a HCPs care of pts should be based solely on each pt's medical
needs and the HCP's medical knowledge and experience.
PhRMA's Goals - Ans 1. Inform HCPs about risks/benefits of products for appropriate pt use
2. Provide scien fic and educa onal info
3. Support medical research and educa on
4. Obtain feedback and advice via consulta on with medical experts
PhRMA Code Sec on 2: Meals - Ans (a) modest as judged by local standards; (b) not part of an
entertainment or recrea onal event; (c) provided in a manner conducive to informa onal
communica on.
**should also be limited to in-office or in-hospital se7ngs, significant others/guests are not
appropriate.
Can't just Drop off food or give grab-and-go.
Dinner programs okay if loca on is conducive to educa on, not too fancy, meal is modest and
incidental to informa onal session
,No meals directly provided at CME events - however 3rd party conferences/prof mee ngs
where CME is only part of the mee ng- company can sponsor meal/recep on
PhRMA Sec on 3: Entertainment & Recrea on - Ans Companies shouldn't provide any
entertainment or recrea onal items (i.e. ckets to the theater or spor ng events, spor ng
equipment, or leisure or vaca on trips) to any HCP who is not a salaried employee of the
company.
Shouldn't be offered regardless of (1) the value of the items; (2) whether the company engages
the HCP as a speaker or consultant; or (3) whether the entertainment or recrea on is secondary
to an educa onal purpose.
PhRMA Code Dont's - Ans 1. no physical gi>s - focus on educa on
2. no pens, mugs, product brochures, etc
3. occasionally items designed to help educate pa ents OR HCP if <$100 (medical book) or
"starter kits"
4. Products of non-educa onal use are not allowed (pedometers, etc)
Nothing that does not advance disease tx or edu, nothing of personal benefit (gas in car)
OIG - Ans Office of Inspector General
OIG Compliance Program Guidance (CPG) for Pharmaceu cal Manufacturers - Ans Compliance
Program Guidance (CPG) was developed with goal of preven ng and reducing fraud and abuse
in federal health care programs.
The purpose of the compliance program guidance is to encourage the use of internal controls to
efficiently monitor adherence to applicable statutes, regula ons and program requirements
*set of guidelines only published in 2003
,OIG Recommended Elements for Pharma CPG - Ans • Implemen ng wriDen policies and
procedures; - Code of Conduct
• Designa ng a compliance officer and compliance commiDee;
• Conduc ng effec ve training and educa on; • Developing effec ve lines of communica on;
• Conduc ng internal monitoring and audi ng;
• Enforcing standards through wellpublicized disciplinary guidelines; and
• Responding promptly to detected problems and undertaking correc ve ac on.
*CPG = Compliance Program Guidance
FDA's mission - Ans To Protect and promote public health. It is a consumer protec on agency
AND a regulatory agency.
Assuring safety, efficacy, and security
Advancing public health
Speeding innova on
Assuring accurate, science-based informa on
What does the FDA not do? - Ans •Regulate physician or healthcare provider prac ce
•Make recommenda ons for individuals (doctors, clinics, care facili es). Dictate the prices of
medica ons.
What does the FDA not regulate? - Ans Adver sing (except Rx-only drugs and medical devices)
alcohol
Meat and poultry
herbal and dietary supplements
drugs of abuse
health insurance
, grocery store water
What does the FDA regulate? - Ans food (including infant formula), drugs, cosme cs and since
2009: cigareDes
MedWatch - Ans FDA's medical safety repor ng program for medical professionals and
consumers
MedWatch Safety Alerts - Ans The FDA publishes safety alerts for FDA-regulated products: Rx
and OTC medica ons, Biologics (aka blood), medical devices, combina on products (nasal
spray), infant formulas, special nutri on products, cosme cs, food
FDA 3500 - Ans Med Watch program repor ng form for healthcare professionals
FDA 3500b - Ans MedWatch program repor ng form for consumers
The Center for Devices and Radiological Health (CDRH) - Ans The FDA center responsible for
for overseeing the medical device program. The FDA monitors reports of adverse events and
other problems with medical devices and when needed, alerts pa ents, health care providers,
industry, and the public.
What is a medical device? - Ans any instrument, apparatus, implement, machine, IMPLANT,
etc...that is intended for the use in diagnosis of disease or other condi ons, or in the cure,
mi ga on, treated, or preven on of disease
What is a "counterfeit medical device" - Ans a fake medical device that is a "copy cat" such as:
a container, package, or label that bears an unauthorized trademark, trade name, or other
iden fying mark or imprint, or any likeness thereof.
liaisons via Medical Science Liaison Society. (MSL-BC)
WITH COMPLETE SOLUTION UPDATED NEW!! 2025/2026
100% VERIFIED CORRECT
PhRMA Code - Ans 1. voluntary code
2. last revised 2021
3. Ensure industry interac ons with HCPs are professional exchanges designed to benefit
pa ents and to enhance the prac ce of medicine
4. Based on the principle that a HCPs care of pts should be based solely on each pt's medical
needs and the HCP's medical knowledge and experience.
PhRMA's Goals - Ans 1. Inform HCPs about risks/benefits of products for appropriate pt use
2. Provide scien fic and educa onal info
3. Support medical research and educa on
4. Obtain feedback and advice via consulta on with medical experts
PhRMA Code Sec on 2: Meals - Ans (a) modest as judged by local standards; (b) not part of an
entertainment or recrea onal event; (c) provided in a manner conducive to informa onal
communica on.
**should also be limited to in-office or in-hospital se7ngs, significant others/guests are not
appropriate.
Can't just Drop off food or give grab-and-go.
Dinner programs okay if loca on is conducive to educa on, not too fancy, meal is modest and
incidental to informa onal session
,No meals directly provided at CME events - however 3rd party conferences/prof mee ngs
where CME is only part of the mee ng- company can sponsor meal/recep on
PhRMA Sec on 3: Entertainment & Recrea on - Ans Companies shouldn't provide any
entertainment or recrea onal items (i.e. ckets to the theater or spor ng events, spor ng
equipment, or leisure or vaca on trips) to any HCP who is not a salaried employee of the
company.
Shouldn't be offered regardless of (1) the value of the items; (2) whether the company engages
the HCP as a speaker or consultant; or (3) whether the entertainment or recrea on is secondary
to an educa onal purpose.
PhRMA Code Dont's - Ans 1. no physical gi>s - focus on educa on
2. no pens, mugs, product brochures, etc
3. occasionally items designed to help educate pa ents OR HCP if <$100 (medical book) or
"starter kits"
4. Products of non-educa onal use are not allowed (pedometers, etc)
Nothing that does not advance disease tx or edu, nothing of personal benefit (gas in car)
OIG - Ans Office of Inspector General
OIG Compliance Program Guidance (CPG) for Pharmaceu cal Manufacturers - Ans Compliance
Program Guidance (CPG) was developed with goal of preven ng and reducing fraud and abuse
in federal health care programs.
The purpose of the compliance program guidance is to encourage the use of internal controls to
efficiently monitor adherence to applicable statutes, regula ons and program requirements
*set of guidelines only published in 2003
,OIG Recommended Elements for Pharma CPG - Ans • Implemen ng wriDen policies and
procedures; - Code of Conduct
• Designa ng a compliance officer and compliance commiDee;
• Conduc ng effec ve training and educa on; • Developing effec ve lines of communica on;
• Conduc ng internal monitoring and audi ng;
• Enforcing standards through wellpublicized disciplinary guidelines; and
• Responding promptly to detected problems and undertaking correc ve ac on.
*CPG = Compliance Program Guidance
FDA's mission - Ans To Protect and promote public health. It is a consumer protec on agency
AND a regulatory agency.
Assuring safety, efficacy, and security
Advancing public health
Speeding innova on
Assuring accurate, science-based informa on
What does the FDA not do? - Ans •Regulate physician or healthcare provider prac ce
•Make recommenda ons for individuals (doctors, clinics, care facili es). Dictate the prices of
medica ons.
What does the FDA not regulate? - Ans Adver sing (except Rx-only drugs and medical devices)
alcohol
Meat and poultry
herbal and dietary supplements
drugs of abuse
health insurance
, grocery store water
What does the FDA regulate? - Ans food (including infant formula), drugs, cosme cs and since
2009: cigareDes
MedWatch - Ans FDA's medical safety repor ng program for medical professionals and
consumers
MedWatch Safety Alerts - Ans The FDA publishes safety alerts for FDA-regulated products: Rx
and OTC medica ons, Biologics (aka blood), medical devices, combina on products (nasal
spray), infant formulas, special nutri on products, cosme cs, food
FDA 3500 - Ans Med Watch program repor ng form for healthcare professionals
FDA 3500b - Ans MedWatch program repor ng form for consumers
The Center for Devices and Radiological Health (CDRH) - Ans The FDA center responsible for
for overseeing the medical device program. The FDA monitors reports of adverse events and
other problems with medical devices and when needed, alerts pa ents, health care providers,
industry, and the public.
What is a medical device? - Ans any instrument, apparatus, implement, machine, IMPLANT,
etc...that is intended for the use in diagnosis of disease or other condi ons, or in the cure,
mi ga on, treated, or preven on of disease
What is a "counterfeit medical device" - Ans a fake medical device that is a "copy cat" such as:
a container, package, or label that bears an unauthorized trademark, trade name, or other
iden fying mark or imprint, or any likeness thereof.
