From Learning Outcomes to
Competencies
EXBO: Brussels 11 July 2012
What is a Competency?
 Competencies encompass knowledge, skills, attitudes, and
behaviours necessary for a particular set of tasks or objectives.
 Professional Competence is defined as ‘the array of abilities
across multiple domains or aspects of professional
performance in a certain context…is multidimensional and
dynamic. It changes with time, experience and setting’.
(Frank, 2010)
 A competent professional is one possessing the required
abilities in all domains in a certain context at a defined stage of
education or practice.
Issues in Bio-Medical Education
 There is a perceived mismatch between graduates from
health care professions and the health system needs.
 Why? : New roles, new demands, technology,
evidence-based medicine, professional fragmentation,
globalisation.
 Heightens the need for reform.
 Growing interest in outcomes-based education, with
government/regulatory support.
Change in educational practices in health
professions education
 Outcomes-based/competency-based education improves
performance, enhances communication, provides an impetus
for faculty development, curricular reform and leadership in
educational innovation. (IOM,2005)
 Competency-based education has begun to redefine
accreditation and certification across the health professions.
(Am.J.Pub Health, 2004)
Traditional Vs Outcomes Based education
TRADITIONAL EDUCATION
OUTCOMES BASED EDUCATION
Inputs are important
Outcomes are important
Time fixed
Outcomes based
Learners grouped in classes and
move together
Learners advance in various ways to
achieve outcomes
Teachers are responsible for a
course
Teachers are responsible for a set
of outcomes
Learners accumulate courses and
grades leading to a credential
Learners demonstrate achievement
of outcomes at their own pace
Defined competencies are
important
Defined competencies are
fundamental
Topics
 Outcomes based education: Why? How?
 Statement of competence and professional relevance
 Alignment of competencies: (IFAPP/CEPM/WGV Vs Faculty of
Pharmaceutical Medicine Vs PharmaTrain Learning Outcomes-based)
 Competencies for Medicines Development Professionals /
Clinical Investigators / Clinical Research Team:
opportunities for synergies and collaboration
Key messages
 Competency-Based Education (CBE) is here to stay
 Core Competencies for Pharmaceutical Physicians and




Medicines Development Professionals have been defined for
professional and education purposes
A Statement of Competence is available for professional use
The PharmaTrain Learning Outcomes and the Core
Competencies (Cognitive level) are fully aligned
Opportunities for development and collaboration of
competencies in clinical research
CBE well-suited to adult education, part-time, modular,
learner-centred, multi-modal, flexible, international E&T
programme.
What is a ‘Competency’?
 Competencies encompass knowledge, skills, attitudes, and
behaviours necessary for a particular set of tasks or objectives.
 Professional Competence is defined as “the array of abilities
across multiple domains or aspects of professional
performance in a certain context…is multidimensional and
dynamic. It changes with time, experience and setting”.
(Frank, 2010)
 A competent professional is one possessing the required
abilities in all domains in a certain context at a defined stage of
education or practice.
Traditional Vs Competency based education
Hierarchy of competencies
Competencies in Pharmaceutical
Medicine/Drug Development Sciences
 Professional Groups expect to have defined competencies.
 On the other hand, the stakeholders expect professional
groups to have defined Competencies.
 PharmaTrain and E&T programmes in Pharmaceutical
Medicine / MDS intend to be Outcomes-Based.
Revision: The Previous Task:
 Align the proposed competencies (CEPM-WGV) with those
from the Specialty Training Curriculum (FPM) and the
Learning Outcomes from the PharmaTrain Curriculum.
 Restrictions/Boundaries:
 6 or 7 domains Vs 12 domains
 < 10 general competencies for each domain
 Feasibility of mapping to the PharmaTrain syllabus /curriculum
 Maintain internal/external validity
 Prepare a Statement of Competence for professional
purposes.
BASE COURSE LEARNING OUTCOMES
SYLLABUS TOPICS
(KNOWLEDGE)
LO1
LO2
APPLIED KNOWLEDGE
SKILLS
ATTITUDES
PP/MDS COMPETENCY
From Learning Outcomes to Competencies
LOx
Domain Benchmarking:
I- Drug Development and Clinical Trials
WGV-CEPM
FPM
PharmaTrain
•Drug Discovery,
Development & Clinical
Pharmacology
•Clinical Pharmacology
•Discovery of Medicines &
Development Planning
•Clinical Research and
Clinical Trials
•Clinical Development
•Non Clinical Testing,
pharmaceutical & early
clinical development
•Statistics & Data
Management
•Exploratory &
Confirmatory clinical
development
•Clinical Trials
Domain Benchmarking:
II- Regulatory Affairs and Safety of Medicines
WGV-CEPM
FPM
•Medicines Regulation: Drug •Medicines Regulation
safety & Pharmacovigilance
PharmaTrain
•Regulatory Affairs, Drug
Safety & Pharmacovigilance
•Drug Safety Surveillance
•Ethics and Subject
Protection
• NA
•NA
Domain Benchmarking:
III- Health Care and Professionalism
WGV-CEPM
FPM
PharmaTrain
•Health Care Market Place
•Health Care Market Place
•Healthcare Market Place:
Economics of Health Care
•Communication &
Information in Health care
•Interpersonal &
Management Skills
•NA
•Leadership, Management &
Professionalism
Final proposal for consideration for Pharmaceutical
Physicians /Medicines Development Professionals
 3 AREAS
 7 CORE DOMAINS
Competence framework
AREA
1. DRUG DEVELOPMENT & CLINICAL
TRIALS
CORE DOMAIN ( competencies)
I
Discovery of Medicines & Early
Development (n=9)
II Clinical Development & Clinical Trials
(n=10)
2. REGULATORY AFFAIRS & SAFETY OF
MEDICINES
III Medicines Regulation (n=10)
IV Drug Safety Surveillance (n=8)
V
3. HEALTH CARE & PROFESSIONALISM
Ethics & Subject Protection (7)
VI Health Care Market Place (n=6)
VII Communication & Management (n=9)
Statement of Competence
for:
 Pharmaceutical Physicians
 Medicines Development Professionals
Statement of Competence: Sources
 PharmaTrain Curricula;
 Pharmaceutical Medicine Specialty Training Curriculum, Faculty of






Pharmaceutical Medicine (FPM);
Consortium of Academic Programs in Clinical Research (CoAPCR);
US Accreditation Council for Graduate Medical Education (ACGME);
American Society of Public Health (ASPH);
Academy of Pharmaceutical Physicians & Investigators (APPI; now APCR);
Clinical and Translational Science Awards/US National Institute of Health
(CTSA);
Medical Leadership Forum/Faculty of Pharmaceutical Medicine (MLF).
I-The Pharmaceutical Physician/
Medicines Development Professional is able:
 To identify unmet therapeutic needs, evaluate the
evidence for a new candidate for clinical development
and design a Clinical Development Plan for a Target
Product Profile. (Domain I)
 To design, execute & evaluate exploratory
& confirmatory clinical trials and prepare manuscripts
or reports for publication & regulatory submissions.
(Domain II)
II- The Pharmaceutical Physician/
Medicines Development Professional is able:
 To interpret effectively the regulatory requirements
for the clinical development of a new drug through
the product life-cycle to ensure its appropriate
therapeutic use & proper risk management. (Domain III)
 To evaluate the choice, application & analysis of
post-authorisation surveillance methods to meet the
requirements of national/international agencies for
proper information & risk minimisation to patients
& clinical trial subjects. (Domain IV)
III-The Pharmaceutical Physician/
Medicines Development Professional is able:
 To combine the principles of clinical research
& business ethics for the conduct of clinical trials
& commercial operations within the organisation.
(Domain V)
 To appraise the pharmaceutical business activities in
the healthcare environment to ensure that they
remain appropriate, ethical & legal to keep the
welfare of patients & subjects at the forefront of
decision making in the promotion of medicines
& design of clinical trials. (Domain VI)
IV- The Pharmaceutical Physician/
Medicines Development Professional is able:
 To interpret the principles & practices of people
management & leadership, using effective
communication techniques & interpersonal skills to
influence key stakeholders & achieve the scientific
& business objectives. (Domain VII)
Competencies by Domain
 Desired Competencies by Domain
 Cognitive Level (Bloom’s taxonomy)
Mapping to PharmaTrain Learning
Outcomes
 The desired competency (cognitive level) was
mapped to the related PharmaTrain Learning
Outcomes (as described in the Base Course
curriculum)
 For Example………………………
Example of mapping competences to
Learning Outcomes
Desired Competency
(Cognitive level)
• Evaluates and analyses a
disease area within the industry
clinical development
environment and identifies
unmet therapeutic needs
• Designs and executes
confirmatory studies and
evaluates the resulting data as
applied to the CDP and the TPP
Source
FPM/CLD1
FPM/CLD4,
SDM1
Related PharmaTrain Learning
Outcome
•Role of patho-physiology and molecular
pharmacology in drug development (M1)
•Principles of Translational research and its role
in drug development (M1)
•Function and elements (including business
aspects) involved in the integrated development
of a new drug (M1)
•Principles and practices of Medical Marketing
(M1a)
Key operational and strategic issues in the
clinical development plan (M4)
Various types of clinical studies and the methods
used to choose the appropriate design (M4)
Main statistical methods used in clinical research
(M4)
Task was completed successfully!
 Aligned the proposed competencies (WGV-CEPM) with
those from the Specialty Training Curriculum (FPM) and
the learning outcomes from the PharmaTrain
Curriculum
 7 domains
 ~ 10 general competencies for each domain
 Mapped to the PharmaTrain Curriculum and Syllabus
 Maintained internal/external validity
 Prepared a Statement of Competence for professional
purposes
Conclusions
 Competency Based Education is here to stay.
 Core Competencies for Pharmaceutical Physicians and
Medicines Development Professionals have been defined
for professional and education purposes.
 A Statement of Competence is available for professional
use.
 The PharmaTrain Learning Outcomes and the Core
Competencies (Cognitive level) are aligned.
 Opportunities for development and collaboration of
competencies in clinical research.
Competence framework
AREA
1. DRUG DEVELOPMENT & CLINICAL
TRIALS
CORE DOMAIN
I
DISCOVERY OF MEDICINES & EARLY
DEVELOPMENT
II CLINICAL DEVELOPMENT &
CLINICAL TRIALS
2. REGULATORY AFFAIRS & SAFETY OF
MEDICINES
III MEDICINES REGULATION
IV DRUG SAFETY SURVEILLANCE
V
3. HEALTH CARE & PROFESSIONALISM
ETHICS & SUBJECT PROTECTION
VI HEALTH CARE MARKET PLACE
VII COMMUNICATION &
MANAGEMENT
Competency achievement:
 On the successful completion of the module /
programme / (interactive) course the
Pharmaceutical Physician / Medicines
Development Professional should be able to:
 >>>>>>>>>>>
Competencies (Cognitive Level)
Area 1: DRUG DEVELOPMENT & CLINICAL TRIALS
Domain I: DISCOVERY OF MEDICINES & EARLY DEVELOPMENT

Evaluate and analyse a disease area within the industry clinical development environment
and identify unmet therapeutic needs.

Evaluate the clinical and non-clinical pharmacology and toxicology evidence for a new
candidate for clinical development.

Evaluate and apply the regulatory and ethical aspects underpinning clinical development.

Create a Clinical Development Plan for a new candidate including a Target Product Profile
(TPP).

Design and execute exploratory studies and evaluates the resulting data as applied to the
Clinical Development Plan.

Contrast the advances made in the clinical pharmacology of a new medicine in a stepwise
manner with the overall Clinical Development Plan and the TPP.

Defend the statistical principles for the design, conduct and assessment of exploratory
studies.

Justify the various end-points used in the clinical development programme.

Appraise suspected adverse events during exploratory development.
BASE COURSE LOs: 1. INTRODUCTORY MODULE & DEVELOPMENT PLANNING
On successful completion of this Module the student should be able to:
1. Outline the process of drug development and identity of critical factors and decision
points.
2. Explain the importance of the patient in drug development.
3. Describe the background to the development of the regulation of medicines and the
role of the competent authorities.
4. Outline the monitoring of drug safety.
5. Describe the principles & practice of medical marketing.
6. Outline the role of pathophysiology and molecular biology-based
pharmacology in drug development.
7. Describe the principal steps in discovering, modifying, assessing and patenting
new chemical and biological compounds (including advanced therapies)
according to their therapeutic indication.
8. Discuss the resource planning (in terms of project management, budgeting and
cost-control) involved in the management of a drug development programme.
9. Describe the principles of translational research and its role in drug
development.
10. Outline the functions and elements (including business aspects) involved in the
integrated development of a new drug.
BASE COURSE LOs: 2. NON-CLINICAL TESTING, PHARMACEUTICAL AND EARLY
CLINICAL DEVELOPMENT
On successful completion of this Module the student should be able to:
1. Discuss the choice & predictive value of the non-clinical testing programme as
part of the overall drug development plan for chemical & biological compounds.
2. Describe the integration of non-clinical tests into the overall drug development
plan (including scheduling of toxicology tests with respect to clinical trials).
3. Outline the steps in the pharmaceutical development of a drug substance and
final drug product (including chemical and biological compounds).
4. Describe the planning of clinical trial supplies for test substance(s) and
comparators (active and placebo).
5. Provide an overview of non-clinical study requirements prior to First-in-Man
studies.
6. Discuss the molecular and cellular basis of toxic reactions.
7. Outline the principles and practical application of pharmacokinetics &
toxicokinetics.
8. Outline the early exploratory development in man.
9. Discuss the principles of clinical pharmacology and their application to clinical
development.
10. Describe the influence of genetic factors in drug development & drug response.
Competencies (Cognitive Level)
Area 1: DRUG DEVELOPMENT & CLINICAL TRIALS
Domain II: CLINICAL DEVELOPMENT AND CLINICAL TRIALS

Evaluate the conduct & management of clinical trials within the context of the Clinical
Development Plan & working as part of a Team.

Design & execute confirmatory studies and evaluate the resulting data as applied to the
Clinical Development Plan & the TPP.

Evaluate & interpret the principles for the development of a clinical trial protocol applying
principles of GCP in clinical pharmacology.

Summarise the principles of Case Record Form Design & clinical data management, including
CDISC, EDC & MedDRA.

Interpret & explain the outcomes of clinical studies.

Support & provide the clinical input into the design & review of a Statistical Analysis Plan.

Appraise & review relevant literature & other sources and write manuscripts for publication.

Create & constructively evaluate clinical study reports & regulatory submissions.

Appraise & design the management of essential documents as defined under GCP
guidelines.

Organise the activities & processes related to the selection & management of sites for
individual or multi-centre clinical trials.
Competencies (Cognitive Level)
Area 2: DRUG DEVELOPMENT AND CLINICAL TRIALS
Domain V: ETHICS AND SUBJECT PROTECTION

Evaluate the impact of cultural diversity & the need for cultural competency in the conduct
of clinical trials & other business activities .

Describe the ethical & professional issues (conflicts of interest, plagiarism, authorship &
intellectual property) associated with clinical research, drug development &
commercialisation on the production of scientific knowledge.

Describe the significance of historical abuses on the evolution of principles of human subject
protection.

Evaluate the key documents related to the ethical conduct of clinical trials & pharmaceutical
marketing operations.

Describe the ethical issues involved when dealing with vulnerable populations, and the need
for additional safeguards.

Compare the requirements for human subject protection & privacy under different national
& international regulations.

Summarise the principles of Corporate Social Responsibility.
BASE COURSE LOs: 3. EXPLORATORY AND CONFIRMATORY CLINICAL DEVELOPMENT
On successful completion of this Module the student should be able to:
1. Describe the early studies in patients: dose-finding / proof of concept studies
and their impact on drug development plan.
2. Outline the design of clinical trials, including legal, regulatory, ethical &
practical aspects and Good Clinical Practice (GCP).
3. Discuss the principles and application of statistics in clinical trials.
4. Describe the procedures for clinical trial data collection (paper & electronic)
and data management (including validation processes) to ensure optimal
quality data.
5. Identify the key strategic and operational issues in the clinical trial process, in
terms of legislative requirements and Good Clinical Practice (GCP).
6. Describe the role of the Investigator Drug Brochure (IDB).
7. Discuss the principles and practical relevance of ethical issues in biomedical
research.
8. Outline the legal and ethical provisions for protection of clinical trial subjects.
BASE COURSE LOs: 4. CLINICAL TRIALS
On successful completion of this Module the student should be able to:
1. Describe the various types of clinical studies & the methods used to choose the
appropriate design.
2. Describe the main statistical methods used in clinical research.
3. Identify the key issues involved in the conduct of a clinical study including
investigator & site recruitment, investigative site management & conflict resolution.
4. Discuss the collection, evaluation & reporting of adverse event data in clinical trials.
5. Outline the various quality management issues in clinical trials.
6. Describe the impact of emerging results on the drug development plan.
7. Outline the key operational and strategic issues in the clinical development plan.
8. Explain the evaluation of the outcome of drug development: final therapeutic
profile / usage of a medicine.
9. Describe the role of the Target Product Profile (TPP) & Target Product Claims (TPC).
10. Explain the role of the Drug Safety Monitoring Board (DSMB) & other relevant
study committees.
11. Discuss the statistical issues in statistical report writing.
12. Describe the evaluation & interpretation of clinical trial results.
13. Illustrate the principles & practical application of critical appraisal.
Competencies (Cognitive Level)
Area 2: REGULATORY AFFAIRS AND SAFETY OF MEDICINES
Domain III: MEDICINES REGULATION

Summarise the legislative framework supporting the development & registration of medicines,
ensuring their safety, efficacy & quality.

Describe the regulations related to post-authorisation safety monitoring & reporting
procedures.

Justify the significance of regular product Safety Update Reports to the regulatory agencies
and participate in their preparation & review.

Evaluate the unlicensed use of medicines and ensure patient safety is paramount.

Describe procedures in the development & renewal of Marketing Authorisations.

Design, prepare, review & evaluate Clinical Overviews for regulatory submission.

Describe the legal framework for clinical trials and the requirements in different regions, and
perceived problems associated with global drug development.

Describe the mechanisms for wider availability of medicines, and undertake or contribute to
product deregulation.

Organise the investigation of product defects, counterfeit products and other miscellaneous
pharmaceutical procedures and requirements.

Describe the principles and process of regulation of medical devices and biotechnology
formulations.
Competencies (Cognitive Level)
Area 2: REGULATORY AFFAIRS AND SAFETY OF MEDICINES
Domain IV: DRUG SAFETY SURVEILLANCE

Contrast the key regulatory requirements for pharmacovigilance, both in the major ICH
regions & locally, and their historical background.

Organise the medical assessments required to meet the requirements for drug safety
reporting both at the level of the individual patient (case report) & aggregate report.

Summarise the spontaneous reporting & signal detection methodologies & assess medically
Adverse Event/Adverse Drug Reaction reports as part of causality assessment.

Summarise the principles & methods of evaluation of risk & benefit balance & the principles
& methods for managing risk to patient & clinical trial subjects.

Discriminate the variety of regulatory actions possible to address concerns about patient
safety.

Describe the importance of communication of safety issues, the variety of formats required
to meet audience needs and contribute to the development of such communications.

Evaluate a safety issue and establish a crisis management team, recognising the key
functional areas to be represented and their roles & responsibilities.

Appraise the areas of progress, likely major advances & future challenges in drug safety &
pharmacovigilance.
BASE COURSE LOs: 5. REGULATORY AFFAIRS; DRUG SAFETY & PHARMACOVIGILANCE
On successful completion of this Module the student should be able to:
1. Describe the general principles of medicines regulation (both pre- & post-approval) at EU & global level.
2. Discuss the impact of medicines legislative requirements on regulatory activities within a pharmaceutical
company.
3. Explain the role of national agencies and international bodies in medicines regulation.
4. Describe the national provisions for management of: (1) off-label / unlicensed use of medicines, and
(2) controlled drugs.
5. Discuss the place of the International Conference on Harmonisation (ICH) in medicines regulation (including
Common Technical Document [CTD]).
6. Explain the regulatory processes in the EU / EEA areas.
7. Describe the regulation & legal considerations of Product Information.
8. Outline the principles & practical application of medical devices regulation.
9. Discuss the roles of the various stakeholders (including pharmaceutical and other healthcare professionals,
investigators, regulatory authorities) in drug safety and pharmacovigilance.
10. Outline the classification of adverse events / adverse drug reactions.
11. Describe the safety reporting requirements (according to the type of adverse event / reaction) pre- & postapproval.
12. Discuss the ongoing management of drug safety issues pre- & post-approval (including Risk Management
Plans [RMPs], Periodic Safety Update Reports [PSURs]); ongoing benefit / risk assessment throughout the
life-cycle of a medicine.
13. Discuss the role of pharmacoepidemiology in the life-cycle management of a medicine.
14. Describe the factors influencing medication safety from the perspective of each stakeholder.
Competencies (Cognitive Level)
Area 3: HEALTHCARE AND PROFESSIONALISM
Domain VI: HEALTHCARE MARKETPLACE

Describe the commercial healthcare environment in which pharmaceutical medicine
operates, identifying the contribution of laws & of regulators & other stakeholders in the
decision making for prescribing medicines.

Summarise the key elements involved in medical/marketing communication in the
healthcare environment, and explainsthe importance of compliance with regulation in this
context.

Describe the pharmaceutical industry: internal environment, structure & function, key
stakeholders & commercial drivers, and explain how these business elements impact on the
broader healthcare market place.

Describe the information required to undertake a commercial analysis of the market
potential for a pharmaceutical product/candidate within the industry business environment.

Appraise the commercial competitor environment when evaluating the opportunity for a
new medicine under development or a currently marketed product.

Describe the interface between pharmaceuticals & the external stakeholder environment,
and the challenges balancing the commercial & professional aspects in making ethical
judgments within the legal/regulatory framework .
BASE COURSE LOs: 6. HEALTHCARE MARKETPLACE; ECONOMICS OF HEALTHCARE
On successful completion of this Module the student should be able to:
1. Illustrate the life-cycle management (clinical, regulatory and marketing)
of medicines.
2. Describe the processes of production and review of product information
to ensure adherence to ethical and legal principles pertaining to marketing
activities (Good Promotional Practice).
3. Discuss the role of patient organisations.
4. Discuss the principles & practical application of health economics and
patient-reported outcomes within the pharmaceutical industry.
5. Outline the principles of health technology assessment (HTA) and its role
in the supply of medicines to the marketplace.
6. Discuss the principles and practice of marketing within the pharmaceutical
industry.
7. Discuss drug budget control; pricing mechanisms.
Competencies (Cognitive Level)
Area 3: HEALTHCARE AND PROFESSIONALISM
Domain VII: COMMUNICATION AND MANAGEMENT

Describe the principles & practices of people management & leadership to apply them within their
own working environment; set learning & improvement goals.

Ensure that the knowledge, skills & behaviours associated with the competent practice of
pharmaceutical medicine are communicated effectively, using the best techniques & practices
whilst participating in the education of colleagues & stakeholders.

Organise networks and builds & maintains relationships, encouraging contribution to & working
with inter-professional teams to meet the business objectives.

Support the success of the organisation by actively contributing to develop strategic plans to
achieve goals, manage resources & people, and leverage performance.

Ensure organisational excellence by developing critical evaluation skills, encouraging
improvement & innovation in managing change.

Identify strengths, deficiencies & limits in one’s knowledge & expertise.

Work effectively as a member or leader of a healthcare team or other professional group.

Explain his/her accountability to key stakeholders, society & the profession of pharmaceutical
medicine.

Apply quality & performance improvement concepts to address organisational performance
issues.
A model of competency (Miller 1990)
DOES
Performance
SHOWS HOW
KNOWS HOW
KNOWS
Simulation
Applied
knowledge
Knowledge
DOES
SHOWS HOW
KNOWS HOW
KNOWS
Assessing the practical modules
 COMPETENCY
 Does the trainee have the knowledge, skills and behaviours to
be able to do the task or project in question to the required
standard?
 Level One - Fully competent
 Level Two - Understands the underlying principles
DOES
SHOWS HOW
KNOWS HOW
KNOWS
Assessing competency
 Outcome
 Real world assessment of activity
 Did it achieve its aim?
 Outputs
 Review results of activity
(documents, targets achieved)
 Has trainee demonstrated competence?
 Observation
 Review activity being done
 Is the trainee demonstrating
competence?
Example
Competency (Area 1; Domain 1: Discovery of Medicines & Early Development).
(Able to) evaluate the clinical and non-clinical pharmacology and toxicology
evidence for a new candidate for clinical development.
Learning Outcomes (PharmaTrain Base Course):
M2.1 Choice & Predictive value of the non-clinical programme as a part of the overall drug
development plan.
M2.2 Integration of non-clinical tests into the overall drug development plan (including
scheduling of toxicology tests with respect to clinical trials.
M2.3 Steps in the pharmaceutical development of a drug substance and the final drug
product (including chemical and biological compounds).
M2.5 Overview of non-clinical study requirements prior to FIM studies.
Syllabus topics: (1.7, 3.2, 3.3, 3.4, 3.5, 3.6, 3.9)
In Vitro & in vivo testing of new compounds (1.7). Differences in non-clinical safety & toxicity
packages between small molecules and biologicals (3.2). The fundamental differences and
similarities between the pharmacology and toxicology of compounds and their metabolites
in animals and man, and their qualitative and quantitative assessment (3.3). The purpose of
descriptive and quantitative in vitro and in vivo testing (3.4). The choice of and the
predictive value of these tests for acute, chronic, reproductive, genetic and immune
toxicology and carcinogenicity (3.5). Common mechanisms of damage to organs and their
detection or elucidation (3.6). The regular review of toxicology, its inclusion into clinical
trial protocols and investigator brochures, and the appropriate planning and correlation with
the clinical evaluation of potential and observed toxicity in patients (3.9).
Competency (Area 1; Domain 1):
(Able to) evaluate the clinical and non-clinical pharmacology and
toxicology evidence for a new candidate for clinical development.
Knowledge: Syllabus topics: 1.7, 3.2, 3.3, 3.4, 3.5, 3.6, 3.9 (as described).
Applied Knowledge:
Demonstrate knowledge of:
 Relevant and current regulations.
 How, in particular, the pharmacology and toxicology data necessary for
Phase 1 studies must be designed, reviewed and approved in
readiness for clinical trials.
 Components of the Clinical Development Plan required in Europe.
Components of a regulatory licensing (marketing) submission required
in Europe.
 Awareness of, and how to obtain advice on, US and Japanese
regulatory needs.
Competency (Area 1; Domain 1):
(Able to) evaluate the clinical and non-clinical pharmacology and
toxicology evidence for a new candidate for clinical development.
Skills:
Demonstrate ability to:
 Define or review the planned clinical pharmacology of the candidate
investigational product before clinical trials are begun.
 Anticipate possible disease-related variations in drug handling in
patients compared with normal healthy subjects.
 React to unexpected findings promptly and , if necessary, suspend
further work while other expert opinions are obtained and the issue is
clarified.
 Describe past problems in this clinical or therapeutic area that have
led to regulatory refusal of trials or their modification.
Competency (Area 1; Domain 1):
(Able to) evaluate the clinical and non-clinical pharmacology and
toxicology evidence for a new candidate for clinical development.
Behaviours / Attitudes:
The Pharmaceutical Physician / Medicines Development Professional:
 Accepts a pivotal role in preparation of a development plan that
requires knowledge & judgement.
 Recognises the value of liaison with other experts in related fields in
the design and interpretation of studies.
 Exhibits strict compliance with regulations and guidelines.
 Understands the need to keep senior management informed.
BASE COURSE LEARNING OUTCOMES
SYLLABUS TOPICS
(KNOWLEDGE)
LO1
LO2
APPLIED KNOWLEDGE
SKILLS
ATTITUDES
PP/MDS COMPETENCY
From Learning Outcomes to Competencies
LOx
Specialist vocational path
 Diploma-level programme (30 ECTS)
 Knowledge, Applied Knowledge
 Assessment, Examination
 Workplace-centred, competency-based
experience (CBE)
 Modular (specialty + general IPM module)
 Educational Supervision
 Framework of assessment, appraisal, review
 Certification, accreditation
 QMS
 Combination Academic / Vocational paths........
Combination academic/vocational paths
(1+2, or 1+3, or 1+2+3)
1. PharmaTrain Base Course (6 Modules)
 Assessments
 Integrated examination
 Diploma (30 ECTS)
2. Extension Modules (4), Elective Modules (2)
 Assessments
 Dissertation / Thesis
 MSc (30+ ECTS)
3. Workplace-centred, Competency-based E&T (CBE)
 ES, assessment, appraisal, review
 Specialty Certificate; specialist title & accreditation
(30+ ECTS)
PharmaTrain:
Workplace-centred, Competency-based
Education & Training Platform for
Pharmaceutical Physicians and
Medicines Development Professionals
Competency-based Programme
 ~55 Learning Outcomes = Base Course Curriculum
 ~60 Competencies = Curriculum
How Delivered?
 All core competencies (~60)
 Core-core competencies (~30)
 Competencies of training experience (~20)
 Job-defined Modules (min. 2/6) (~20 CC);
supplementary courses (~40)
Additional
 General core competencies: Interpersonal &
Management Skills
Requirements for Competency-based
programme
 Professional / vocational track (not academic)
 Training Plan (job/project orientation)
 Educational Supervision
 ES training, approval, standards
 Assessment of competency
 Outcomes, Outputs, WPBAs (tools)
 Evidence of Competency (validated, authenticated, realistic)
 Portfolio, Training Record, e-Portfolio
Requirements for Competency-based
programme
 Appraisal (Educational & Annual Performance)
 Review of progress & achievement (e.g. Annual)
 Competency-based Courses
 Interactive, multi-modal, assessments (to Miller level of
simulation), course QMS
 QMS of programme
 Outcome / qualification (e.g. European MS-CCT)
 Specialist in Pharmaceutical Medicine;
Medicines Development
 Certification / Accreditation body
 Legal, recognised, sets standards for good practice