MSL Accreditation Criteria
Accreditation Criteria
for Medical Science Liaison Certification
Program
Perspective/ Evaluation Criteria
December 1, 2014
The Japanese Association of Pharmaceutical
Medicine
1
MSL Accreditation Criteria
Glossary
The definition of abbreviations and terminology used in this document in alphabetical order:
ABM
CIOMS
CONSORT
Advisory Board Meeting
Council for International Medical Science
Consolidated Standards of Reporting Trials
GCP
GPSP
GVP
Healthcare Professional
Good Clinical Practice
Good Post-marketing Study Practice
Good Vigilance Practice
ICH
ICMJE
Industry sponsored study
Any member of the medical, pharmacy or nursing professions
International Conference on Harmonization
International Committee of Medical Journal Editors
A clinical trial, study, basic research sponsored by pharmaceutical or other companies
from a planning phase
Investigator sponsored study
A clinical trial, study, basic research sponsored by investigators from a planning phase
KPI
Key Performance Index
MR
Medical Representative
MSL
Medical Science Liaison※, who has high-level of medical/ scientific expertise, knowledge
and degrees, internally/ externally helps to promote the proper use of medicines and the
maximization of product value, from medical/ scientific perspectives. There is a clear
distinction between their activities and the promotional sales activity. MSLs meet with
key opinion leaders and medical researchers to communicate/ obtain medical
information through medical/ scientific exchanges and conference activities.
※
Also known as Medical Scientific Liaison
QC
QA
Quality Control
Quality Assurance
2
MSL Accreditation Criteria
Table of contents
1.
Independence from promotional activities (Compliance structure)
1.1. Internal positioning of MSL department
1.1.1. MSL reporting line independent of Sales and Marketing departments
1.1.2. Independence from MR role
1.1.3. Independence from other departments that engage in promotional activities
1.1.4. Branch-deployed MSL independent of a sales role in a branch
1.2. Compliance structure
1.2.1. Archive of providing reprints (scientific document/journal)
1.2.2. Providing information on pre-marketed drugs/off-label use
1.2.3. Procedure for MSL interaction with HCPs
1.2.4. Scope of information MSL is allowed to provide to HCPs
1.2.5. Review structure of the materials MSL uses
1.2.6. Lecture meetings organized by MSL department
1.2.7. ABM organized by MSL department
1.2.8. Preliminary review of presentation of lecture meeting and manuscripts
1.2.9. Investigator sponsored study
1.2.10. Company sponsored study
1.2.11. Research grant
1.2.12. Ensuring company-wide compliance
1.2.13. Hotline and management structure
1.3. Assessment system
1.3.1. Performance assessment
1.3.2. KPIs independent of Sales and Marketing departments
1.3.3. Ensuring transparency in assessment
2.
Medical and scientific expertise
2.1. Scientific exchange with HCPs
2.1.1. Providing medically and scientifically fair information
2.1.2. Providing information on off-label use/pre-marketed drugs
2.2. Attendance at medical and scientific conferences
2.2.1. Reporting the latest medical/ scientific information
2.3. Support for research activities
2.3.1. Communication with HCPs on investigator sponsored studies
2.3.2. Internal review and research grant for investigator sponsored studies
2.3.3. Communication with HCP on company sponsored studies
2.4. Support for relevant departments
2.4.1. Medical/ scientific assessment of materials used by Sales and Marketing departments
2.4.2. Sharing new information obtained through MSL activity
2.4.3. Contribution to mid-to-long term directions for treatment in a disease area (life cycle
management)
2.4.4. Providing off-label information in response to a request made by Sales and Marketing
departments
2.5. Involvement in ABM
2.5.1. Appropriate communication conforming to the objective of ABM
3
MSL Accreditation Criteria
2.6. Involvement in publication
2.6.1.
MSL as a scientist, author, or reviewer
2.6.2. HCP consultation on publication
2.7. Creating materials
2.7.1. Materials based on the latest medical/ scientific information
3.
Educational system
3.1. Qualification requirements
3.1.1. Clarifying qualification requirements
3.2 Educational program
3.2.1. Knowledge based training
3.2.2. Competency based training
3.3 Training content
3.3.1. Business basics
3.3.2. Organization management
3.3.3. Industry regulation and code of conduct
3.3.4. Research ethics
3.3.5. Medical studies
4
MSL Accreditation Criteria
1. Independence from promotional activities (Compliance structure)
1.1. Internal positioning of MSL department
1.1.1. MSL reporting line independent of Sales and Marketing departments
【Perspective】
◇ MSL is independent of Sales and Marketing department, and their role is positioned as
scientific activities that are not regarded as promotional in nature.
【Evaluation criteria】
● In the organization chart, MSL is independent of Sales and Marketing department.
● The division of duties for MSL department is clearly defined.
● Records to be kept
➢ Organization chart
➢ Division of duties
1.1.2.
Independence from MR role
【Perspective】
◇ MSL activity is clearly differentiated from that of MR. The environment is set up or
improved so as to avoid confusion with MR activity from a HCPs’ perspective.
【Evaluation criteria】
● The role and responsibility of MSL/ MR are clearly defined.
● The differences between MSL/ MR materials are clearly defined.
● Records to be kept
➢ Division of duties
➢ Documents that describe the code of conduct/ role and responsibilities, job description
of MSL and MR
1.1.3.
Independence from other departments that engage in promotional activities
【Perspective】
◇ MSL is independent of other departments that engage in promotional activities. The
environment is developed so as to allow activities that are not regarded as promotional in
nature.
【Evaluation criteria】
● MSL department has strategy and activity plan developed by their department which is
independent of Sales and Marketing departments.
5
MSL Accreditation Criteria
● The SOP for internal review is developed so that the strategies and activity plans developed
by MSL department are not regarded as promotional activities, and review records are
kept.
● Records to be kept
➢ Activity plan
➢ Internal review records
1.1.4.
Branch-deployed MSL independent of a sales role in a branch
【Perspective】
◇ The environment is developed so that branch deployed MSL is independent of a sales role
in a branch and is able to conduct activities that are not regarded as promotional in nature.
【Evaluation criteria】
● The MSL report line is independent of a branch organization.
● The SOP is defined for how a branch member makes a request to MSL.
● Records to be kept
➢ Response to a request made by a branch member
1.2. Compliance structure
1.2.1. Archive of providing reprints(scientific document/journal)
【Perspective】
◇ The SOP for providing reprints is developed and followed.
【Evaluation criteria】
● The SOP for providing reprints is put in place, and records of provided reprints are kept.
● The criteria for choosing providable articles are defined.
● Records to be kept
➢ Provided article reprints
1.2.2.
Providing information on pre-approval drugs/ an off-label use
【Perspective】
◇ The SOP for providing information on pre-approval drug/ an off-label use is put in place
and followed.
◇ Information is provided in response to a request from HCP, and is explained in a way that
does not induce use.
【Evaluation criteria】
● The SOP for providing information on pre-approval drug/ an off-label use※ is put in place,
and
records
of
providing
information
are
kept.
6
MSL Accreditation Criteria
※
The SOP is created for both MR and MSL, respectively, in case they receive a request.
● The list of unapproved drugs/ off-label information is updated on a regular basis.
● The selection criteria for providable articles are defined.
● Records to be kept
➢ Records of providing information/ explanation (including the reasons why the provided
information is chosen)
➢ Reasons why the articles are chosen, and a list of provided reprints (if reprints are
provided)
1.2.3.
Procedure for MSL interaction with HCP
【Perspective】
◇ The environment is developed so that MSL can conduct scientific activities that are not
regarded as promotional in nature when they meet with HCP.
◇ The objectives of interaction include collecting customers’ unmet medical needs.
【Evaluation criteria】
● Sales and Marketing colleagues are not allowed to be present during interactions between
MSL and HCP, except for a brief introduction of MSL by Sales and Marketing colleagues
during the first meeting.
● The SOP for MSL activities is put in place, and interaction records are kept.
● Records to be kept
➢ Interactions
1.2.4.
Scope of information MSL is allowed to provide to HCPs
【Perspective】
◇ The clear criteria are set up for the objectives of interactions between MSL and HCP to
avoid being regarded as promotional in nature.
◇ Information given by MSL to HCP is scientific and not biased.
【Evaluation criteria】
●
●
●
●
●
●
●
MSL interaction with HCP is scientific, objective and not biased.
Provided information is based on the grounds and well-balanced.
Non-promotional.
Provided information contains mainly generic names, not brand names.
The SOP for internal review of MSL materials is put in place, and review records are kept.
Only internally-reviewed-and-approved MSL materials are used.
Records to be kept
➢ Internal review
➢ Approved MSL materials
7
MSL Accreditation Criteria
1.2.5.
Review structure of MSL materials
【Perspective】
◇ The internal review structure is put in place to check whether information provided with
the use of MSL materials is appropriate as non-promotional activities.
【Evaluation criteria】
● The SOP for the internal review of MSL materials is put in place, and review records are
kept.
● Records to be kept
➢ Internal review records
➢ Approved MSL materials
1.2.6.
Lecture meeting organized by MSL department
【Perspective】
◇ Symposia organized by MSL are held independently from Sales and Marketing
departments.
【Evaluation criteria】
● Symposia are hosted by MSL department that is independent of Sales and Marketing
departments.
● Symposia are scientifically fair and neutral, not biased, and well-balanced in content.
● The logo and colors associated with a certain brand are not used in a symposium venue.
● The logo and colors associated with a certain brand are not used in the slides to be used in
symposia.
● Sales and Marketing employees are not allowed to attend MSL department-organized
symposia for the purpose of promotion. (It is acceptable to support events outside the
venue or to listen to presentations for a self-learning purpose.)
● The SOP is put in place for the internal review of symposium planning and presentation
topics, and review records are kept.
● Records to be kept
➢ Internal review records
➢ Materials used at symposia, such as slides
➢ Symposia proceedings
1.2.7.
ABM organized by MSL department
【Perspective】
◇ ABMs organized by MSL are held independently from Sales and Marketing departments.
【Evaluation criteria】
● ABMs are hosted by MSL department that is independent of Sales and Marketing
8
MSL Accreditation Criteria
departments.
● Sales and Marketing employees are not allowed to attend MSL department-organized
ABMs. (It is acceptable for MSL to give medical/ scientific presentation as a medical expert
at ABMs organized by Marketing. If the discussion point in ABM will be related safety or
rightness of usage, minimal attendees from Marketing will be allowed.)
● The objective of ABM is to collect opinions, and the time used by MSL department to give
input accounts for less than half.
● The logo and colors associated with a certain brand are not used in an ABM venue.
● The logo and colors associated with a certain brand are not used in the slides to be used in
ABMs.
● ABM attendees are chosen based on clear criteria.
● The SOP is put in place for the internal review of ABM planning and its content, and review
records are kept.
● Records to be kept
➢ Internal review records
➢ Materials used at ABMs, such as slide
➢ ABM proceedings
1.2.8.
Preliminary review of presentation summaries and manuscripts
【Perspective】
◇ A preliminary review structure is put in place for presentation summaries and manuscripts.
【Evaluation criteria】
● The SOP is put in place for the internal review of presentation summaries and manuscripts,
and review records are kept.
● Records to be kept
➢ Internal review records
1.2.9.
Investigator sponsored study
【Perspective】
◇ A department independent of Sales and Marketing uses fair and objective judgment in
communication for investigator sponsored studies.
◇ Communication for investigator sponsored studies is not regarded as promotional in
nature.
◇ MSL smoothly handles a request, either directly from HCP or via Sales/ Marketing
department, by using optimal internal communication/ reporting process.
◇ MSL is capable of promptly and appropriately sorting out how to deal with each request,
including the decision to accept or not, in accordance with internal/ industry rules.
【Evaluation criteria】
● The SOP is put in place for communication for investigator sponsored studies, and
9
MSL Accreditation Criteria
communication records are kept.
● It is ensured that communication for investigator sponsored studies is not regarded as
promotional in nature.
● An internal review structure independent of Sales and Marketing departments is
responsible for review processes.
● The SOP for the internal review of investigator sponsored study plans is put in place, and
review records are kept.
● Communication is appropriate and within the scope of on-label information.
● A written consent is obtained from investigators regarding support for investigator
sponsored studies.
● Progress is monitored on a regular basis.
● Records to be kept
➢ Communication
➢ Internal review records
➢ The outcome of a study supported by MSL
➢ Progress
1.2.10. Company sponsored study
【Perspective】
◇ When planning company sponsored studies, MSL communicates with HCP in an
appropriate way, and conforms to internal/ external rules when understanding medical
needs or selecting centers.
【Evaluation criteria】
● The SOP is put in place for communication for company sponsored studies, and
communication records are kept.
● It is ensured that communication for company sponsored studies is not regarded as
promotional in nature.
● An internal review structure independent of Sales and Marketing departments is
responsible for review processes.
● The SOP for the internal review of company sponsored study plans, and review records are
kept.
● Progress is monitored on a regular basis.
● Records to be kept
➢ Communication
➢ Internal review records
➢ The outcome of a study supported by MSL
➢ GCP/GPSP training attendance
1.2.11. Research grant
【Perspective】
◇ A department independent of Sales and Marketing uses fair and objective judgment in
10
MSL Accreditation Criteria
handling research grant.
◇ Research grant is provided in a way that is not regarded as promotional in nature.
◇ Transparency is ensured around research grant by signing a contract.
【Evaluation criteria】
● The SOP is put in place for research grant, and records are kept.
● It is ensured that providing research grant is not regarded as promotional in nature.
● An internal review structure independent of Sales and Marketing departments is
responsible for review processes.
● The SOP for research grant is put in place, and review records are kept.
● Investigators are obliged to report the outcome of a study.
● The consent to comply with transparency guidelines is obtained.
● Records to be kept
➢ Communication
➢ Internal review records
➢ The outcome of a study for which research grant is provided
➢ Contract
1.2.12. Ensuring company-wide compliance
【Perspective】
◇ Company-wide compliance is ensured and maintained by using an appropriate checkup/
feedback system.
◇ Information held by MSL department is managed to avoid the misuse for promotional
activities.
【Evaluation criteria】
● The SOP is put in place for the regular/ irregular checkup structure of compliance related
materials/ records, and checkup records are kept.
● A cycle is put in place to collect feedback from HCP to improve.
● Training plan for compliance is developed and implemented.
● Sales and Marketing employees are not allowed to access detailed information of
investigator sponsored studies held by MSL department.
● Records to be kept
➢ Checkup
➢ Compliance training attendance
1.2.13. Hotline and management structure
【Perspective】
◇ A hotline and its management structure are put in place to mutually oversee compliance.
【Evaluation criteria】
11
MSL Accreditation Criteria
● A compliance hotline is put in place.
● Employees in relevant departments are aware of the hotline.
1.3. Assessment system
1.3.1.
Performance assessment
【Perspective】
◇ Evaluators of MSL activity and their department are clearly independent of Sales and
Marketing departments.
【Evaluation criteria】
● MSLs are evaluated by a report line independent of Sales and Marketing departments.
● An objective evaluation system with multiple evaluators is put in place.
1.3.2.
KPIs independent of Sales and Marketing departments
【Perspective】
◇ MSL KPIs are independent of sales-related items, and are set up as non-promotional
activities.
【Evaluation criteria】
● KPIs are not set for promotional activities.
● KPIs are not set for MSL activities that may be regarded as promotional in nature.
1.3.3.
Ensuring transparency in assessment
【Perspective】
◇ Transparency is ensured for MSL activity evaluation. The environment is created so that
evaluated MSL can file complaints against evaluation results.
【Evaluation criteria】
●
●
●
●
The SOP is put in place for the evaluation of MSL activity, and records are kept.
Evaluation criteria are clearly shown.
The process for filing complaints against evaluation results and HR hotline are put in place.
Records to be kept
➢ Evaluation results
2. Medical and scientific expertise
12
MSL Accreditation Criteria
2.1. Scientific communication with HCPs
2.1.1. Providing medically and scientifically fair information
【Perspective】
◇ Information is provided based on appropriate materials/ articles.
➢ MSL uses materials appropriately reviewed from medical perspectives.
➢ MSL uses articles appropriately chosen (Articles are not chosen in a biased manner.)
◇ MSL works to increase knowledge by collecting the latest scientific information
comprehensively.
【Evaluation criteria】
●
●
●
●
MSL materials are reviewed appropriately from medical perspectives.
The standards for providing reprints are defined.
MSL attends conferences/ scientific trainings, and collects the latest scientific information.
Records to be kept
➢ Review
➢ Information provision (interaction with HCP)
➢ Attendance reports of conferences/ scientific trainings
2.1.2.
Providing information on an off-label use/ pre-marked drugs
【Perspective】
◇ MSL provides fair information by using articles grounded on medical and scientific
evidences in a way that is not regarded as promotion for an off-label use/ an unapproved
drug.
【Evaluation criteria】
● MSL provides fair information by using articles grounded on medical evidences in a way
that is not regarded as promotion for an off-label use/ an unapproved drug.
● Records to be kept
➢ Provided information (Interaction with HCP)
➢ An article list (if reprints are provided)
2.2. Attendance at medical and scientific conferences
2.2.1. Collecting the latest medical/ scientific information
【Perspective】
◇ Information not only on company products but also on competing products in relevant
disease areas, as well as the latest studies, diagnostics, and treatment, is shared
appropriately among internal stakeholders.
【Evaluation criteria】
● The SOP is put in place for information handling, and information is managed.
13
MSL Accreditation Criteria
● Records to be kept
➢ Attendance reports of conferences/ scientific trainings
2.3. Support for research activities
2.3.1. Communication with HCP on investigator sponsored studies
【Perspective】
◇ MSL smoothly handles a request, either directly from HCP or via Sales/ Marketing
department, by using appropriate internal communication/ reporting.
【Evaluation criteria】
● Medical and scientific nature is ensured through communication with investigators, such as
providing medical/ scientific information and article information in an appropriate way.
● What MSL can do other than information provision is clarified and records are kept.
● Progress is monitored on a regular basis.
● Records to be kept
➢ Communication
➢ Internal review
➢ The outcome of a study supported by MSL
2.3.2.
Internal review and research grant for investigator sponsored studies
【Perspective】
◇ An internal review process is established to ensure medical/ scientific nature.
◇ If providing research grant is determined as appropriate, an application is submitted in
accordance with internal rules and research grant is provided based on a contract.
◇ Transparency is ensured in each process to be prepared for audit.
【Evaluation criteria】
● The SOP for internal review is put in place, and review records are kept.
● Investigator sponsored study plans are internally reviewed for their relevance in medical/
scientific nature.
● The SOP for research grant and contract is put in place, and records are kept.
● MSL conforms to an internal approval route.
● MSL appropriately understands institution-specific rules and makes adjustments.
● MSL respects transparency guidelines.
● MSL adheres to internal SOPs, including global ones.
● Records to be kept
➢ Internal review application for study concept and protocol
➢ Internal review
➢ External review
➢ Contract
➢ Research grant
14
MSL Accreditation Criteria
➢ Progress management
➢ Other materials
2.3.3.
Communication with HCP on company sponsored studies
【Perspective】
◇ When planning studies, MSL communicates with HCP in an appropriate way, and conforms
to internal/ external rules when understanding medical needs or selecting centers.
【Evaluation criteria】
● Medical and scientific nature is ensured through communication with investigators, such as
providing medical/ scientific information and article information in an appropriate way.
● Progress is monitored on a regular basis.
● MSL appropriately understands and handles institution-specific rules.
● Records to be kept
➢ Communication
➢ Progress
2.4. Support for relevant departments
2.4.1. Medical/ scientific assessment of materials used by Sales and Marketing departments
【Perspective】
◇ MSL edits or supervises materials created by Sales and Marketing department, which are to
be used for promotion, from medical/ scientific perspectives within the locally approved
scope.
【Evaluation criteria】
● Materials are consistent with the latest publication.
● The consistency with PIs and safety information is ensured.
● Materials are not biased in favor of the value or advantages of company products from
medical/ scientific perspectives.
2.4.2.
Sharing new information obtained through MSL activity
【Perspective】
◇ New medical information obtained through daily MSL activity is organized and shared with
relevant departments in an understandable and appropriate manner. In that case, a
decision is made on whether obtained information may be shared or not depending on its
nature/ type, and independence is ensured from promotional activity.
【Evaluation criteria】
● The SOP for internal information sharing is put in place, and information is managed.
15
MSL Accreditation Criteria
● An internal information sharing route and rules for sharing are made clear.
➢ A sharable scope is set.
➢ Shared information is appropriately organized and managed.
➢ An efficient information provision method is established.
➢ MSL does not share information beyond MSL activity, with Sales and Marketing
departments.
2.4.3.
Contribution to mid-to-long term directions for treatment in a disease area (life cycle
management)
【Perspective】
◇ Information obtained through MSL activity is shared with other departments for the proper
use of company products or for the purpose of supporting mid-to-long term directions for
treatment in a disease area.
【Evaluation criteria】
● The SOP for internal information sharing is put in place, and information is managed.
● An internal information sharing route and rules for sharing are made clear.
➢ A sharable scope is set.
➢ Shared information is appropriately organized and managed.
➢ An efficient information provision method is established.
➢ Medical/ scientific perspectives that are not biased in favor of company products
2.4.4.
Providing off-label information in response to a request made by Sales and Marketing
departments
※ Please refer to “2.1.2 Providing information on an off-label use/ an unapproved
drug”
2.5. Involvement in ABM
2.5.1. Appropriate communication in conformity of the objective of ABM
【Perspective】
◇ MSL engages in communication regarding invitation to ABM, objectives and reasons,
assumed/ expected discussion topics, and ABM contracts. (before ABM)
◇ MSL appropriately follows up on discussion results at ABM, including subsequent actions.
(after ABM)
【Evaluation criteria】
● Medical and scientific nature of ABM is ensured through communication with HCPs who
are ABM members, such as providing medical and scientific information in an appropriate
manner. MSL keeps the following in mind when engaging in communication:
16
MSL Accreditation Criteria
➢ MSL checks institution-specific rules when inviting HCPs and organizing ABM. (before
ABM)
➢ MSL collects views and requests from invited members and links them to ABM. (before
ABM)
➢ MSL agrees with HCP on the finalization of the minutes and discussion results. (after
ABM)
● Records to be kept
➢ Communication
➢ Advisory board contract※
➢ Payment※
※ The role and responsibilities of MSL, specified by each company, need to be taken into account.
2.6. Involvement in publication
2.6.1. MSL as a scientist, author, or reviewer
【Perspective】
◇ When a request is made to publish data of industry sponsored studies or to write
manuscripts for journals, MSL fully experienced as an author or reviewer handles the
request, ensures scientific validity, and follows internal/ external rules.
【Evaluation criteria】
● The SOP for publication is put in place, and records are kept.
● The selection criteria for internal reviewer are defined.
● Records to be kept
➢ Internal review trail
➢ Articles, conference presentation slides, posters
➢ MSL’s publication list
2.6.2.
HCP consultation on publication
【Perspective】
◇ When receiving a request from HCP for consultation on publication, MSL discusses based
on medical and scientific grounds, does not provide a service for free and carefully
considers COI.
【Evaluation criteria】
● The SOP for HCP consultation is put in place, and support is managed.
● Records to be kept
➢ Consultation support
2.7. Creating materials
2.7.1. Materials based on the latest medical/ scientific information
17
MSL Accreditation Criteria
【Perspective】
◇ Articles quoted in MSL materials are not arbitrarily chosen, and created materials are
medically reviewed, fair and neutral.
【Evaluation criteria】
● The SOP is put in place for the medical review of MSL materials, and records are kept.
● The standards are defined for providing reprints.
● Records to be kept
➢ Review
➢ Created material
3. Educational system
3.1. Qualification requirements
3.1.1. Clarifying qualification requirements
【Perspective】
◇ MSL qualification requirements are clearly defined in the job description. Those who meet
the requirements are deployed, performing as MSLs.
【Evaluation criteria】
● The following qualification requirements are provided:
➢ Medical / pharmaceutical / scientific academic background (bachelor, master, PhD and
MD degrees) and academic activities such as congress presentation and writing articles;
those without scientific background must have experiences that are equivalent to the
above.
➢ Working years (contents and the number of years).
➢ Internal and external training related to MSL job.
➢ Certified if there is an internal certification program.
➢ Certificate from the pharmaceutical industry/ academic societies.
➢ Certificate of English ability.
➢ Internal evaluator for MSL requirements.
3.2. Educational program
3.2.1. Knowledge based training
【Perspective】
◇ The training program consisting mainly of knowledge based lectures on the basics of
medicine/ pharmacy/ medical science and medical products is systematically organized and
implemented. The program attendees can learn and understand their knowledge
appropriately.
18
MSL Accreditation Criteria
【Evaluation criteria】
● The following items are covered:
➢ Syllabus, curricula, definition of learning results
➢ Definition of introductory and continuous trainings in curricula
➢ Selection criteria for lecturers
➢ Level of understanding in attendees (exams, pass rate, question validity)
➢ Requirements for evaluators
➢ How to deal with those who did not pass
➢ Certificate renewal and expiration
➢ Procedure for quality control (QC)/ quality assurance (QA) of programs
➢ Program improvement process based on the feedback (questionnaire) from attendees
➢ Use of external courses (academic society training programs) and its evaluation method
3.2.2.
Competency based training
【Perspective】
◇ The training program consisting mainly of competency based exercises on the knowledge
of medicine/ pharmacy/ medical science and medical products is systematically organized
and implemented. The program attendees can acquire their practical skills.
【Evaluation criteria】
● The following items are covered:
➢ Definition of practical skill items (competency development) and areas linked to the
learning outcomes of knowledge based training program
➢ An annual training plan (role-play, OJT)
➢ Definition of evaluators (an internal mentor/ supervisor and evaluation organization)
➢ Evaluation method (regular meeting with a mentor/ supervisor and annual evaluation)
➢ Feedback from evaluators, including external customers
➢ How to deal with those who did not pass
➢ Certificate renewal and expiration
➢ Procedure for quality control (QC)/ quality assurance (QA) of programs
➢ Program improvement process based on the feedback (questionnaire) from attendees
3.3. Training content
3.3.1. Business basics
【Perspective】
◇ The training is organized so as to acquire basic and essential knowledge and business skills
necessary to work in the pharmaceutical industry, as a member of a company and the
society.
【Evaluation criteria】
● The following items are covered:
19
MSL Accreditation Criteria
➢ Communication skills
➢ Business manners (including the training of attitude to customers)
➢ Risk management and business continuity plan
3.3.2.
Organization management
【Perspective】
◇ The training is organized so as to acquire and improve the basic knowledge and skills for
managing people/ organization in a corporate structure.
【Evaluation criteria】
● The following items are covered:
➢ Management skills
➢ Leadership
➢ Mentorship and coaching
3.3.3.
Rules and codes in the pharmaceutical industry
【Perspective】
◇ The training is organized so as to acquire basic knowledge about regulations on promotion,
which serves as the principals for activities independent of Sales and Marketing divisions.
【Evaluation criteria】
● The following items are covered:
➢ Pharmaceutical Affairs Act and related rules
➢ Fair Trade Council guidelines and related notifications
➢ Regulations related to pharmaceutical products and medical equipments
➢ COI guidelines
➢ International rules, such as FCPA, that apply to Japan
➢ Internal code of conduct
3.3.4.
Research ethics
【Perspective】
◇ The training is organized so as to fully acquire ethical knowledge for planning and
conducting medical science studies, especially clinical studies.
【Evaluation criteria】
● The following items are covered:
➢ Declaration of Helsinki and its historical background
➢ Research policies and guidelines in Japan
➢ Regulations related to pharmaceutical products and medical equipments
20
MSL Accreditation Criteria
3.3.5.
Medical scientific studies
【Perspective】
◇ The training is organized so as to fully acquire knowledge about rules and guidelines
necessary for basic researches, clinical studies, conference presentation, and writing
papers.
【Evaluation criteria】
● The following items are covered:
➢ ICH-GCP, J- GCP
➢ CIOMS statement
➢ GVP, GPSP
➢ Clinical study guidelines
➢ CONSORT statement
➢ ICMJE manuscript submission rules
➢ Disease guidelines, including how to develop them
21