Pharma Law
What is this: “any written, printed or graphic material on the drug, on any of its containers or wrappers, or on any material accompanying it.”
Labeling
Clinical trials are regulated globally by ICH guidance. What is ICH?
International Committee on Harmonization
What is: “creating a product or service’s identity in the customers mind”?
Positioning
Segmentation
Messaging
Positioning
What does MSL stand for?
Medical Science Liaison
What is a PRB and what does it do?
Promotional Review Board- a committee that reviews all the promotional materials.
Includes Marketing, Regulatory, Legal & Medical
Which 2 countries allow for Direct-To-Consumer advertising?
US
New Zealand
Phase I clinical trials are typically conducted in HEALTHY volunteers in which disease states?
Cardiovascular?
Cancer?
Rare diseases?
Cardiovascular- YES
Cancer- NO
Rare diseases- NO
Which segment of the population would you target for Insulin? Give examples
i.e. patients with diabetes, A1c>9%, uncontrolled diabetes, inpatient
Which is NOT an MSL responsibility?
A. Training speakers and sales representatives
B. Gathering insights from KOLs
C. Selling drugs
C. Selling drugs
What is a “KOL”?
Key Opinion Leader
What kind of Ad is this?
1)Reminder Ad
2)Product Claim Ad
3)Help Seeking Ad
Product Claim Ad
How long after IND submission must a company wait to start any trials?
30 days
What are the 4 P’s of Marketing?
Price
Promotion
Product
Place
Is the following metric a possible evaluation measure for SALES representatives or MSL?
# of prescriptions for drug
Sales reps
What type of resource consists of the most common anticipated questions from HCPs?
Medical Information letters
What type of Ad is this and what is incorrect on this Ad?
The lungs (no context)
Claim: Breathe easy
with no risk mentioned
Missing generic name
Which trials are primarily used for regulatory labeling purposes?
Phase III
What is an example of Promotional marketing activities?
see slide
Is the following metric a possible evaluation measure for SALES representatives or MSL?
# of presentations
MSL
Which team is responsible for sharing data in journals?
Publications
Name + Use = ??
Safety!!!
Clinical trial data is entered by sites through a…?
case report form
Which of the following marketing tactics can be used PRE Launch?
A. Coming soon advertisements
B. Disease state education
C. Sales force (representatives)
A and B
Which type of employee may only respond to questions ON label?
1. Sales
2. Medical Information
3. Medical Science Liaison
Sales
Which team is responsible for communicating data to customers?
MSL team