Pharmaceutical Industry Overview

Learning objectives:

At the completion of this activity, the participant will be able to:

• Identify the global needs driving the growth of the pharmaceutical industry
• Compare and contrast the different functions (medical affairs, legal regulatory, clinical operations, clinical development, and commercial) within the pharmaceutical industry
• Define the drug development process and path to approval
• Recognize the role that the supply chain process plays in ensuring that pharmaceutical products are delivered to patients in both a timely manner and with high quality assurance
• Describe the primary function of health economics outcomes research

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Compliance

Learning objectives:

At the completion of this activity, the participant will be able to:

• Define First Tier quality system-related requirements and "Compliance" in the context of compliance quality systems for drugs, biologics, and medical devices
• Define Second Tier quality system-related requirements and "Compliance" in the context of the: 21 Code of Federal Regulations (CFR) Part 50 - Protection of Human Subjects Domestic; 21 CFR Part 56 - Institutional Review Board International; and 21 CFR Part 58 - Good Laboratory Practice for Non-Clinical Laboratory Studies
• Describe a plan for the Compliance and Third Tier-related requirements, including CFR Part 7 - Enforcement Policy

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These have been designated Knowledge (K)-type activities.

Target Audience: Physicians, pharmacists, and PhDs who work in Medical Affairs in the pharmaceutical industry.

Cost to participate: $99 (you have already paid)

Credits Available:

For Physicians - maximum of 3.00 AMA PRA Category 1 Credit(s)™

This CME activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through ScientiaCME. This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of ScientiaCME and the Accreditation Council for Medical Affairs. ScientiaCME is accredited by the ACCME to provide continuing medical education for physicians. ScientiaCME designates this educational activity for a maximum of [3] AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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For Pharmacists

ScientiaCME designates the following modules within the MACC program for continuing education activity for a maximum of 3.00 contact hour(s) (0.3 CEUs). These modules are listed below:

• Pharmaceutical Industry Overview: 0574-9999-20-047-H04-P: 2.00 contact hours (0.2 CEUs)
• Compliance: 0574-9999-20-050-H03-P: 1.00 contact hour (0.1 CEU)*

*May be used to satisfy pharmacy law CEU requirements in states that require it.

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These learning activities are being provided jointly by ACMA and ScientiaCME. ScientiaCME is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This activity is provided free of commercial support.
Release date: 10/01/2020
Expiration date: 9/30/2021

Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact CME@medicalaffairsspecialist.org

Instructions for Participation and Credit

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 80% on the post-test

Follow these steps to earn CME/CPE/CE credit*:

1. Read the target audience, learning objectives, and author disclosures.
2. Study the educational content online.
3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test.
4. Once you have completed the program, you can print the certificate from online. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.
5. Pharmacists: must provide their dates of birth (MMDD) and NABP e-ID numbers to ACMA either before successfully passing the post-test or within one month after doing so. The CPE statement provided contains information provided to NABP from the Accreditation Council for Pharmacy Education (ACPE) via CPE Monitor®. ACPE policy states paper and/or electronic statement of credit may no longer be distributed directly to learners as proof of ACPE credit. The official record of credit may be located in the learner’s e-profile in CPE Monitor®.

*The credit that you receive is based on your username profile.

Pharmacoeconomics

Learning objectives:

At the completion of this activity, the participant will be able to:

• Define models of pharmacoeconomic analysis
• Compare and contrast cost benefit effectiveness analysis
• Describe direct and indirect costs and the concept of discounting
• Compare and contrast assessment of costs
• Assess health outcomes assessment studies
• Describe the steps involved in the analysis of pharmacoeconomic studies

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These have been designated Knowledge (K)-type activities.

Target Audience: Physicians, pharmacists, and PhDs who work in Medical Affairs in the pharmaceutical industry.

Cost to participate: $99 (you have already paid)

Credits Available:

For Physicians - maximum of 1.00 AMA PRA Category 1 Credit(s)™

This CME activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through ScientiaCME. This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of ScientiaCME and the Accreditation Council for Medical Affairs. ScientiaCME is accredited by the ACCME to provide continuing medical education for physicians. ScientiaCME designates this educational activity for a maximum of [1] AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

---

For Pharmacists

ScientiaCME designates the activity for a maximum of 1.00 contact hour(s) (0.1 CEUs).

• Pharmacoeconomics: 0574-9999-20-049-H04-P: 1.00 contact hour (0.1 CEU)

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These learning activities are being provided jointly by ACMA and ScientiaCME. ScientiaCME is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This activity is provided free of commercial support.
Release date: 10/01/2020
Expiration date: 9/30/2021

Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact CME@medicalaffairsspecialist.org

Instructions for Participation and Credit

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 80% on the post-test

Follow these steps to earn CME/CPE/CE credit*:

1. Read the target audience, learning objectives, and author disclosures.
2. Study the educational content online.
3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test.
4. Once you have completed the program, you can print the certificate from online. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.
5. Pharmacists: must provide their dates of birth (MMDD) and NABP e-ID numbers to ACMA either before successfully passing the post-test or within one month after doing so. The CPE statement provided contains information provided to NABP from the Accreditation Council for Pharmacy Education (ACPE) via CPE Monitor®. ACPE policy states paper and/or electronic statement of credit may no longer be distributed directly to learners as proof of ACPE credit. The official record of credit may be located in the learner’s e-profile in CPE Monitor®.

*The credit that you receive is based on your username profile.

Diagnostics industry

Learning objectives:

At the completion of this activity, the participant will be able to:

• Describe various segments of diagnostics industry and how it differs from the pharmaceutical and medical device industries
• Compare and contrast the different types of diagnostics tests (diagnostic segments)
• Discuss the most common in vitro diagnostic tests (diagnostic segments)
• Compare and contrast the advantages and disadvantages of point of care diagnostics
• Recognize the regulations of in vitro diagnostics
• List the FDA requirements for IVD products

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Cost to participate: $99 (you have already paid)

Credits Available:

For Physicians - maximum of 1.00 AMA PRA Category 1 Credit(s)™

This CME activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through ScientiaCME. This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of ScientiaCME and the Accreditation Council for Medical Affairs. ScientiaCME is accredited by the ACCME to provide continuing medical education for physicians. ScientiaCME designates this educational activity for a maximum of [1] AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

---

For Pharmacists

ScientiaCME designates the following activity for a maximum of 1.00 contact hour(s) (0.1 CEUs). These modules are listed below:

• Diagnostics Industry: 0574-9999-20-048-H04-P: 1.00 contact hour (0.1 CEU)

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These learning activities are being provided jointly by ACMA and ScientiaCME. ScientiaCME is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This activity is provided free of commercial support.
Release date: 10/01/2020
Expiration date: 9/30/2021

Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact CME@medicalaffairsspecialist.org

Instructions for Participation and Credit

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 80% on the post-test

Follow these steps to earn CME/CPE/CE credit*:

1. Read the target audience, learning objectives, and author disclosures.
2. Study the educational content online.
3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test.
4. Once you have completed the program, you can print the certificate from online. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.
5. Pharmacists: must provide their dates of birth (MMDD) and NABP e-ID numbers to ACMA either before successfully passing the post-test or within one month after doing so. The CPE statement provided contains information provided to NABP from the Accreditation Council for Pharmacy Education (ACPE) via CPE Monitor®. ACPE policy states paper and/or electronic statement of credit may no longer be distributed directly to learners as proof of ACPE credit. The official record of credit may be located in the learner’s e-profile in CPE Monitor®.

*The credit that you receive is based on your username profile.

Compliance

Learning objectives:

At the completion of this activity, the participant will be able to:

• Define First Tier quality system-related requirements and "Compliance" in the context of compliance quality systems for drugs, biologics, and medical devices
• Define Second Tier quality system-related requirements and "Compliance" in the context of the: 21 Code of Federal Regulations (CFR) Part 50 - Protection of Human Subjects Domestic; 21 CFR Part 56 - Institutional Review Board International; and 21 CFR Part 58 - Good Laboratory Practice for Non-Clinical Laboratory Studies
• Describe a plan for the Compliance and Third Tier-related requirements, including CFR Part 7 - Enforcement Policy

---

These have been designated Knowledge (K)-type activities.

Target Audience: Physicians, pharmacists, and PhDs who work in Medical Affairs in the pharmaceutical industry.

Cost to participate: $99 (you have already paid)

Credits Available:

For Physicians - maximum of 3.00 AMA PRA Category 1 Credit(s)™

This CME activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through ScientiaCME. This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of ScientiaCME and the Accreditation Council for Medical Affairs. ScientiaCME is accredited by the ACCME to provide continuing medical education for physicians. ScientiaCME designates this educational activity for a maximum of [3] AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

---

For Pharmacists

ScientiaCME designates the following modules within the MACC program for continuing education activity for a maximum of 3.00 contact hour(s) (0.3 CEUs). These modules are listed below:

• Compliance: 0574-9999-20-050-H03-P: 1.00 contact hour (0.1 CEU)*

---

*May be used to satisfy pharmacy law CEU requirements in states that require it.

These learning activities are being provided jointly by ACMA and ScientiaCME. ScientiaCME is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This activity is provided free of commercial support.
Release date: 10/01/2020
Expiration date: 9/30/2021

Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact CME@medicalaffairsspecialist.org

Instructions for Participation and Credit

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 80% on the post-test

Follow these steps to earn CME/CPE/CE credit*:

1. Read the target audience, learning objectives, and author disclosures.
2. Study the educational content online.
3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test.
4. Once you have completed the program, you can print the certificate from online. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.
5. Pharmacists: must provide their dates of birth (MMDD) and NABP e-ID numbers to ACMA either before successfully passing the post-test or within one month after doing so. The CPE statement provided contains information provided to NABP from the Accreditation Council for Pharmacy Education (ACPE) via CPE Monitor®. ACPE policy states paper and/or electronic statement of credit may no longer be distributed directly to learners as proof of ACPE credit. The official record of credit may be located in the learner’s e-profile in CPE Monitor®.

*The credit that you receive is based on your username profile.