PHARMACEUTICAL GLOSSARY

PHARMACEUTICAL. MEDICAL DEVICE. BIOTECH.

A

ADVISORY BOARDS

Organizing a group of external healthcare experts to get professional insight on a specific healthcare topic.

AGGREGATE SPEND

Typically tied to specific type of reporting, aggregate spend refers to process of monitoring the total amount of money that healthcare manufacturers spend when working with healthcare professionals and organizations. A few examples of what this total "spend" includes are honoraria, travel, lodging and food and beverage. This internal data process is built around compliance with the Sunshine Act also known as the Open Payments Act.

AREA OF CARE

This refers to an HCP's specific area of study and practice. A few examples of areas of care are oncology, cardiology, dermatology and nephrology .

ATTENDEE ENGAGEMENT

The degree to which event attendees, both in-person and virtual, interact with the event and it's experience. A few examples of how this can be measured is through virtual engagement tools, on-site evaluation or post-event surveys.

ATTENDEE VERIFICATION

Attendee verification is an essential process in pharmaceutical events. Event spend is highly monitored in the pharmaceutical and medical device industries, with a per-person spending cap being a key report post-event. This is done two ways. The first during the registration process. The HCP registrant must connect to their NPI profile, proving themselves to be a health care provider, or register to be added to the NPI database and be manually approved. After the attendee has successfully registered and the event date has arrived, the guest will be again verified as being a legitimate attendee via being noted as a virtual attendee or completing the sign in when they arrived on-site, providing the necessary documentation for post-event reporting.

B

BIOTECH / BIOTECHNOLOGY

Connecting biology and technology, biotechnology uses biology to further scientific development for humans, and other living beings. Related fields to biotech are chemistry, genetic engineering, and molecular biology.

BUSINESS RULES

Typically specific to each company, business rules define the processes that their internal team must abide by to remain compliant. These rules, regulations, and reporting require additional awareness outside standard federal compliance, from their staff and vendor partners.

C

CLINICAL TRIAL

A research study that tests the safety and effectiveness of new medical treatments including: drugs, devices, and procedures. The trial compares the new treatment to existing treatments on their effectiveness. Additionally, they determine what side effects the new treatment may impose.

CLOUD / CLOUD-BASED

A platform or system whereby data is stored, managed, and processed on a network of remote servers hosted on the internet, rather than on local servers or personal computers.

COMPLIANCE

The healthcare industry has laws, regulations, and guidelines specific to the development, manufacturing, labeling, advertising, marketing, and distribution of their products. Compliance is a broad term for these regulations and the reporting that accompanies them. Companies like PharMethod can help navigate these regulations to ensure our clients engage with their health care providers and share information on their products in a way that abides by the current regulations and provides all necessary reporting for any auditing down the line.

COMPLIANCE TRAINING

This refers to education on the guidelines mentioned in the Compliance definition. Apart from government regulations which all healthcare manufactures should be aware of, many companies have their own personal "business rules" which are rules, regulations, and reporting that are specific to that company and require additional awareness outside standard federal compliance, from their staff and vendor partners.

CONGRESSES

Events typically organized by healthcare manufacturers where professionals share industry developments and knowledge to keep up to date in an every changing and forward-moving industry.

D

DISEASE STATE EDUCATION (DSE) CONFERENCE / MEETING

Disease State Education typically takes place in an event setting where healthcare professionals will speak about a specific medical condition, educating other hcps on the disease, its symptoms, its causes, diagnosing it, and the treatment options. These are typically an indirect method of marketing. A healthcare manufacturer may sponsor a Disease State event who has a treatment available among its offerings.

E

EMAIL CAMPAIGN

An email campaign is a series of emails sent to multiple recipients at once to achieve a specific goal. Email lists are often segmented for marketing purposes. Email campaigns can be used to target a segment of an audience with a specific message that is topical and relevant to the selected recipients. These emails are specific to the brand and message being conveyed and have personalized information such as name and event attended. The goal of an email campaign can be to:

Promote a product or service
Announce a new product launch
Communicate updates like policy changes or a loyalty program
Collect data about subscribers
Build trusting relationships with subscribers
Keep subscribers engaged with relevant content
Nurture leads
Raise brand awareness
Get customer feedback

F

FIELD SALES

A sales method in which reps travel to meet current or prospective customers in person. In the pharmaceutical industry, this typically equates to on-site or in-office visits.

G

H

HCP (HEALTH CARE PROVIDER / PROFESSIONAL / PRACTITIONER)

HCP is an acronym for health care provider/professional/ or practitioner. A few examples of HCPs include doctors, physicians, dentists, psychologists, dieticians, nurses and pharmacists.

HCP ENGAGEMENT

HCP (Healthcare Provider) engagement refers to healthcare manufacturers building relationships with HCPs in order to communicate developments in treatment options, clinical studies, and other medical developments related to their area of care. Read more about HCP engagement in our comprehensive HCP Engagement Guide.

HCP RECRUITMENT

When hosting speaker bureau or other marketing events, healthcare manufacturers need to ensure they can reach their desired relevant audience to invite them to attend. This is done through HCP recruitment which has multiple methods including email campaigns.

HCP TARGETING

HCP (Healthcare Provider) targeting is a marketing strategy that consists of segmenting HCPs based on specific characteristics, such as area of care. After segmentation, HCPs may receive tailored communications or program invitations determined by the segment that they belong to. By targeting communications and marketing to specific segments, it allows the marketing team to receive more accurate analytics on the success of a campaign or outreach initiative, as they already know the content is relevant for the recipient.

HEALTHCARE

Healthcare is a system that provides services and products to improve the health and well-being of individuals and communities. It includes a wide range of services, such as:

Prevention: Vaccinations and other measures to prevent the spread of disease
Diagnosis: Identifying illnesses, injuries, and other health issues
Treatment: Curing or treating illnesses, injuries, and other health issues
Rehabilitation: Helping people recover from injuries or illnesses
Maintenance: Keeping people healthy and well
Monitoring: Keeping track of people's health
Counseling: Providing guidance and support

Healthcare is delivered by many different types of health professionals, including doctors, nurses, psychologists, and others. Healthcare can take place in many different settings, such as hospitals, urgent care facilities, and other healthcare systems. The main goals of healthcare are to improve the quality of care and patient outcomes, and to reduce the cost of care.

HONORARIA EXPENSE MANAGEMENT

Honoraria is payment granted in recognition of a service. In cases relevant to PharMethod's services, this would refer to honoraria as payments to healthcare provider (HCP) speakers and key opinion leaders. Within compliance regulations, there is a maximum, an "expense cap", that each HCP can be granted annually. This regulation is in place to ensure speakers are not overused, and multiple points of view are shared when educating HCPs about a product.

I

INDICATION

The FDA approved use of a drug to treat, prevent or diagnose a medical condition or disease. A drug can be approved to treat multiple conditions and therefore have multiple indications or uses.

INDICATION UPDATE

After a drug is active on the market, the manufacturer may file for an additional indication or treatment use. This would lead to an indication update.

INVESTIGATOR MEETING

These meetings consist of a group of healthcare providers (HCPs) that had been a part of a clinical trial where the discuss progress and the results of the trial.

IMPORTANT SAFETY INFORMATION (ISI)

A disclaimer that includes the drug's risks, side effects, as well as its approved use and users. ISIs are required on all marketing materials associated with a product as well as with the product itself when it is purchased or prescribed. It is important to consider this when designing marketing materials, event invitations, etc.

J

K

KEY OPINON LEADER (KOL)

An experienced, known, and highly respected medical professional who is educated on a topic to which they can share information with other HCPs or the public. KOLs are typically physicians, researchers, academics, etc.

KOL EDUCATION / TRAINING

Attendee verification is an essential process in pharmaceutical events. Event spend is highly monitored in the pharmaceutical and medical device industries, with a per-person spending cap being a key report post-event. This is done two ways. The first is during the registration process. The HCP registrant must connect to their NPI profile, proving themselves to be a health care provider, or register to be added to the NPI database and be manually approved. After the attendee has successfully registered and the event date has arrived, the guest will be again verified as being a legitimate attendee via being noted as a virtual attendee or completing the sign in when they arrived on-site, providing the necessary documentation for post-event reporting.

KOL MANAGEMENT

Synonymous with HCP or speaker education/training, once a KOL or speaker is selected to speak on behalf of a specific condition, brand, or manufacturer, they must be adequately educated on the topics through reviewing educational materials as well as what guidelines they have to abide by to ensure they remain within compliance.

L

LIFE SCIENCE

"Life science" refers to the scientific study of living organisms and their life processes, encompassing fields like biology, botany, zoology, microbiology, and physiology, essentially examining all forms of life on Earth, including humans, animals, plants, bacteria, and viruses; it investigates how these organisms function, interact with each other, and affect their environment.

LUNCH AND LEARNS

A casual style of event where a KOL or pharmaceutical educator may stop in an office, purchase lunch for the present HCPs and share information on a medical condition or treatment option.

M

MARKET ACCESS

The concept of ensuring patients can obtain prescribed medications and treatments when needed, for a reasonable price, and with appropriate insurance coverage. An employee who works on the market access team, may negotiate with insurance companies, and government healthcare programs to arrange coverage or reimbursements for their products.

MEDICAL CONGRESS MEETINGS

Typically a larger meeting or conference that focuses on a specific field of medicine that can include segments promoting new developments in the field to relevant healthcare professionals (HCPs).

MEDICAL DEVICE

A medical device is a tool, machine, or other instrument used to diagnose, treat, or prevent a disease or condition. Medical devices can also be used to detect, measure, or modify the body's structure or function. Examples of medical devices include: tongue depressors, heart pacemakers, medical imaging equipment, surgical equipment, syringes, gloves, and baby incubators.

Medical devices are different from pharmaceuticals, which are chemical in nature and interact with the body's metabolic or immune system. Medical devices are generally mechanical and have an inert effect on the body.

MEDICAL, LEGAL & REGULATORY (MLR) Review

Synonymous with PRC (Promotional Review Committee), MLR is the process in which a team, typically consisting of medical, legal, and regulatory professionals, ensure drug or medical device promotional materials (advertisements, invitations, sales aids, etc.) are medically accurate, include all necessary language (important safety information, prescribing information, etc.), and are compliant to FDA and company-specific regulations prior to release.

N

NATIONAL BROADCAST

A National Broadcast is a digitally hosted event whereby live presenters address groups usually comprised of hundreds if not thousands of targeted attendees for the purpose of sharing information for promotional or educational outcomes. National Broadcasts generally provide a one-to-many engagement experience which does not allow for direct input or dialog due to the large audience size. However, some platforms allow for engagement and insight gathering through novel digital tools.

O

ON-SITE MANAGEMENT

Onsite meeting management is the process of ensuring that all the details are taken care of on the day of an event. This includes making sure the venue matches the client's brief, following all protocols, and managing the event's staff, suppliers, and other services.
Onsite meeting management responsibilities can include:

Venue setup: Ensuring the venue matches the client's brief, including décor, A/V, and IT
Staff management: Recruiting, managing, and providing on-site support for event staff
Supplier management: Planning and contracting with third-party suppliers
Protocol management: Ensuring all protocols are followed, especially for security
Registration: Managing onsite registration and participant assistance
Food and beverage: Planning and organizing food and beverage service points
Signage: Planning and managing signage for the venue
Safety and security: Planning and managing safety and security protocols
Speaker management: Coordinating speakers, including their AV needs and handouts
Entertainment: Managing entertainment and show production

OPEN PAYMENTS ACT

Synonymous with the Sunshine Act and Transfer-of-Value Reporting(TOV). This act requires the disclosure of any financial payments of transfers of value made by healthcare manufacturers to healthcare professionals to a publicly accessible database. It was enacted in 2010 as part of the Affordable Care Act (ACA) to increase transparency in financial relationships between HCPs and manufacturers.

P

PATIENT PROGRAMS

Patient Programs are educational events conducted in live, virtual, or on-demand formats that serve the purpose of sharing relevant information on diseases and methods of controlling or managing symptoms for an improved quality of life. In many cases Patient Programs are conducted with one or more licensed medical professionals acting as the primary voice or voices; however, it is common for patients or patient advocates to act as presenters as well on their own, or in partnership with said licensed medical professionals. Patient Programs are a powerful educational forum as they leverage peer driven information and coaching to the targeted audience for an authentic learning experience.

PEER-TO-PEER

Peer-to-peer programs are specifically developed to encourage healthcare professionals (HCPs) to discuss among their peers, developments in their specific field or new/alternative treatment strategies.

PHARMACEUTICAL EVENT MANAGEMENT

Pharmaceutical Event Management for HCPs is a term used to describe a broad array of logistical support services provided by third party vendor partners in the arena of promotional or educational events such as advisory boards, steering committee meetings, speaker training meetings, and speaker programs. The goals of the Pharmaceutical Event Management partner is to simplify the process leading up to the event for the sponsoring organization and all participating HCPs or Health Care Providers who may be planning to present or attend said event. Pharmaceutical Event Management partners handle sourcing of venues, managing contracts for venues and HCP participants, tracking all spends and registrations, managing HCP attendee travel and lodging as needed, collecting pertinent financial data for satisfactory Transfer of Value and Aggregate Spends reporting, and more.

PHARMACEUTICAL HCP TRAINING

Synonymous with KOL or speaker education/training, once a KOL, speaker, or HCP is selected to speak on behalf of a specific condition, brand, or manufacturer, they must be adequately educated on the topics through reviewing educational materials as well as what guidelines they have to abide by to ensure they remain within compliance.

PhRMA CODE

PhRMA Code is a code of ethics that guides interactions between healthcare manufacturers and HCPs in the United States. The code is based on ethical standards, legal guidelines, and encouraging trust with patients. Manufacturers who publicly commit to PhRMA code and certify that they are in compliance with the code are included on PhRMA's website: https://phrma.org/About

PRODUCT INFORMATION (PI)

A document intended for HCPs sharing technical information on a drug or product's safety, effectiveness, and limitations.

PRODUCT LAUNCH MEETINGS

A product launch meeting is a gathering that marks the start of the pre-release phase for a new product or service. It's a chance to outline the strategy and deliverables for the launch, and to align the team on marketing, sales, and customer engagement.

PRODUCT SLIDE LIBRARIES

A product slide library is a centralized collection of slides, templates, and other marketing materials that can be used to create presentations:

Purpose: A product slide library provides a single source of marketing materials for sales and marketing teams. It can help align marketing and sales efforts by ensuring sales representatives have access to up-to-date, on-brand materials.
Organization: Slides can be organized by product, client group, or sales phase.
Features: A product slide library can include features like:
Central updating: A central updating function keeps information like product descriptions and prices up to date.
Reusable slides: A product slide library can include universal slides that can be used in any presentation.
Version tracking: A product slide library can track changes made to slides and locate the latest version.

PRODUCT THEATER

Typically organized by a brand's marketing team, a product theater is a presentation where a pharma/med device company showcases a product at a conference or event.

PRODUCT TRAINING

A program or presentation that educates relevant healthcare professionals (HCPs) on the function, benefits, and risks of a pharmaceutical product or medical device.

PROMOTIONAL REVIEW COMMITTEE (PRC)

Synonymous with MLR (Medical Legal & Regulatory) Review, PRC is the process in which a team, typically consisting of medical, legal, and regulatory professionals, ensure drug or medical device promotional materials (advertisements, invitations, sales aids, etc.) are medically accurate, include all necessary language (important safety information, prescribing information, etc.), and are compliant to FDA and company-specific regulations prior to release.

Q

R

REGULATORY AFFAIRS

Regulatory affairs refers to external compliance monitoring agencies such as the FDA (Food & Drug Administration). They work to ensure healthcare products and others are safe and effective. Additionally they monitor the marketing, development, and manufacturing of products to ensure they are within compliance of the law.

S

SALES REP TRAINING / SALES TRAINING

Sales rep training is a process that teaches sales representatives how to sell more effectively by providing them with the skills and knowledge they need to succeed. The goal of sales training is to improve sales performance, increase productivity, and enhance customer relations.

SPEAKER BUREAU MANAGEMENT

The organization and management of a program that educates healthcare professionals (HCPs) about a pharmaceutical product of medical device. Management of these programs includes the coordination of the speaker selection, the speaker's travel/accommodations, the venue, catering, presentation materials, invitations, attendees, budget/spend reporting, recording/broadcasting for virtual/hybrid viewers, and more. Read our complete guide to Speaker Bureau Management to learn more.

SPEAKER CONTRACTING

Once a qualified speaker is selected to present at your event, an approved contract must be created outlining expectations, event dates, honoraria, and terms for cancelled events or breach of contract.

SPEAKER DEBARMENT SCREENING

Debarment in the pharmaceutical industry can represent either a temporary or permanent restriction of a healthcare professional (HCP) from working with or for the pharmaceutical industry. When selecting a speaker to represent or educate other HCPs about a product, the speaker must pass a debarment screening, to ensure they are not present on the U.S. Food and Drug Administration's (FDA) debarment list.

SPEAKER TRAINING / EDUCATION

Synonymous with HCP or KOL education/training, once a KOL or speaker is selected to speak on behalf of a specific condition, brand, or manufacturer, they must be adequately educated on the topics through reviewing educational materials as well as what guidelines they have to abide by to ensure they remain within compliance.

SPEAKER EXPENSE PAYMENTS

Speaker expense payments are payments made to cover the expenses of a speaker, in addition to their fee for a speaking engagement. These expenses can include: Airfare, Hotel, Food, and Ground transportation.

A speaker fee is a payment made to a speaker for a speech or workshop, where the amount is agreed upon before the event. The speaker or consultant usually determines the amount of the fee.

An honorarium is a voluntary payment made to a speaker or volunteer to help cover costs, but it's not the same as a speaker fee. The host institution usually determines the amount of an honorarium.

SPEAKER (FAIR MARKET VALUE) FMV RATES

Fair Market Value (FMV) rates for speakers are the price that a speaker should be paid for their services that is based on the market's willingness to pay for those services. FMV rates are important for ensuring that healthcare professionals (HCPs) are compensated fairly and that companies are complying with laws and regulations.
When determining FMV for speakers, some characteristics that may be considered include:

Years of professional experience
Specialty type
Number of peer-reviewed publications
Compliance training
Product training
Editorial boards
Investigator experience
Leadership positions
Academic appointments

Companies can also use baseline qualifications for speakers, such as a certain number of years of practice, to establish hourly fee ranges.

SPEAKER HONORARIA

SPEAKER HONORARIA PAYMENTS

A speaker honorarium is a voluntary payment made to a speaker or lecturer for their participation in an event. When considering an honorarium, it's important to consider the speaker's travel and recovery time. For example, one hour of speaking might require three days of work: one day for practicing, one day for travel and delivery, and one day for returning to normal routine.

SPEAKER MANAGEMENT

Synonymous with KOL management, this is the process of identifying, and assessing relevant KOLs and adding them to your speakers bureau. Once part of your bureau, management includes processing honoraria, sharing relevant informational content including slide decks and other materials, organizing travel and accommodations for events, managing any speaker caps present from compliance guidelines, and completing all reporting and payments are within regulation.

SPEAKER NOMINATION

When a healthcare provider (HCP) is selected as a representative for a pharmaceutical or medical device company or brand. Once nominated a speaker would have to be vetted and trained to be a speaker or key opinion leader for a product.

SPEAKER OFFICE OF INSPECTOR GENERAL (OIG) SCREENING

This screening is in place to ensure there are no violations of the Anti-Kickback Statute (ASK), that programs are educational, that speaker/KOL's compensation is representative of fair market value and more.

SPEAKER RECRUITMENT

Speaker recruitment is the process of finding and contacting individuals to speak at an event or conference or as part of a bureau.
Research: Learn about the speaker's background, interests, and achievements.
Contact: Be clear and concise about the event details, speaker compensation, and expectations such as minimum number of programs/presentations per month, quarter, or year.
Follow up: Confirm the speaker's interest and availability.
Sign contracts: Make sure to sign contracts and make payment

SPEAKER VETTING

Speaker vetting is the process of evaluating potential speakers for an event to ensure they are appropriate for the audience and the event's objectives. It can help ensure that the speaker's message is appropriate, that they are familiar with the event's topic, and that they are able to engage with the audience.

SATELLITE SYMPOSIA

Satellite symposia are educational events that are held alongside larger conferences or meetings. They are often sponsored by industry and can be CME-accredited. Satellite symposia can be in-person or virtual, and they can include presentations, lectures, posters, workshops, and group discussions.

SUNSHINE ACT

Synonymous with the Open Payments Act and Transfer-of-Value Reporting(TOV). This act requires the disclosure of any financial payments of transfers of value made by healthcare manufacturers to healthcare professionals to a publicly accessible database. It was enacted in 2010 as part of the Affordable Care Act (ACA) to increase transparency in financial relationships between healthcare providers or HCPs and manufacturers.

SYMPOSIUMS

A meeting or conference which can consist of presentations, roundtables, panels, and workshops.

T

TRAINING PLATFORMS

A training platform is a software or digital system that helps companies create, manage, and track training programs for employees and customers.

Features and Tools: how-to videos, interactive activities, quizzes, virtual labs, and games.

Purposes: onboarding new hires, compliance training, employee education, and customer education.

Outcome of Use: Training platforms can help organizations improve their workforce's skills, knowledge, and performance. They can also help companies track the progress of their organization, identify skills gaps, and determine the ROI of learning and development.

TELECONFERENCING

A general term for live communication between people who are remote from each other. Teleconferencing can include audio teleconferencing, video teleconferencing, and computer teleconferencing.

TRANSFER-OF-VALUE(TOV) REPORTING

Synonymous with the Open Payments Act and Sunshine Act. This report includes the disclosure of any financial payments of transfers of value made by healthcare manufacturers to healthcare professionals to a publicly accessible database. It was enacted in 2010 as part of the Affordable Care Act (ACA) to increase transparency in financial relationships between healthcare providers or HCPs and manufacturers.

U

V

VENUE CONTRACTING

Venue contracting is the process of signing an agreement with a location provider to use their venue for an event. The agreement, or venue contract, establishes the courts that have jurisdiction over any disputes that may arise between the parties. Venue contracts can include many different clauses, such as:

Reservations: The method of reservations, cutoff date, and check-in and check-out times
Cancellation policy: The policy for canceling reservations
Compensation for dishonored reservations: What the venue will provide if guests are "walked"
Alcohol policies: What is allowed and what happens if the policies are violated
Force majeure: The circumstances under which a full refund may be available

Venue contracts are important for managing risk and protecting the interests of all parties. They can help ensure that the event runs smoothly and that everyone involved is aware of their rights and responsibilities.

VIDEO CONFERENCING

VIRTUAL MEETING

Events typically organized by healthcare manufacturers where professionals share industry developments and knowledge to keep up to date in an every changing and forward-moving industry.

W

WEB CONFERENCING

A general term for online meeting solutions that includes webinars, webcasts, and web meetings. Web conferencing is often used for large groups and one-way communication, such as training seminars, webinars, and professional presentations. It's typically accessed through a web browser and a link to an event. Web conferencing is good for broadcasting a single message or speech, but it can have issues with frozen images and pixilation due to low bandwidth.

WEB CONFERENCE SERVICES

Web and teleconference services are online communication tools that allow people to exchange information in real time. Examples include, Web conferencing, Teleconferencing & Video conferencing.

Web conferencing is often used as an umbrella term for different types of meeting solutions. Providers of these services may offer a combination of software, IT, and customer service solutions.

X

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