Pharmaceutical Medicine CESR Portfolio Guide

Specialty Specific CiP 1

• Identifies areas of unmet medical need and related evidence gaps.
• Provides clinical input into product profiling and positioning.
• Contributes to the development of Health Technology Assessments (HTAs).
• Engages in pharmacoeconomic procedures associated with health technology commercialisation.
• Keeps the welfare and interests of patients and clinical trial participants at the forefront of decision-making.
• Provides effective procedures giving patients access to unlicensed medicines.
• Participates in liaising with regulators regarding patient engagement in medicines development.
• Participates in activities that influence the development lifecycle of medicines.
• Identifies and engages with stakeholders in the provision of medicines; facilitates the collection of qualitative data and feedback on the safe and effective use of medicines.
• Participates in generating strategic insights affecting the use of medicines.

Specialty Specific CiP 2

• Aptitude to work within local, regional and international regulatory and ethical frameworks, recognising guidelines and applying patient-centred good practices.
• Able to author, review, revise medical components for regulatory submissions both locally and regionally.
• Able to formulate responses to regulatory and health authorities, and research ethics committees.
• Complies with all codes of practice applicable to the biopharmaceutical industry
• Undertakes internal mandatory training, follows applicable Standard Operating Procedures (SOPs), and has an aptitude for continuous quality improvement in the workplace.
• Keeps up to date with regulations and assesses the impact of regulatory change on medicines development and lifecycle management.

Specialty Specific CiP 3

• Generates information and conducts data analysis.
• Undertakes scientific and medical writing and review.
• Prepares reviews/reports; presentations/publications.
• Identifies relevant data sources.
• Reviews the medical and scientific literature.
• Reviews critically scientific and medical research publications.
• Discusses and interprets statistical principles and applications in the development of medicines.
• Contributes to the analysis and review of regulatory documents.
• Contributes to the creation and review of strategic and policy documents.
• Utilises systems to maintain data quality, integrity and confidentiality.

Specialty Specific CiP 4

• Applies the principles of pharmacokinetic and pharmacodynamic assessments, modelling and simulation, and exposure-effect relationships in clinical trial design and oversight.
• Assesses and contributes to the design of early phase (exploratory) clinical development programmes and clinical trials.
• Communicates the design of a clinical trial and the potential risks and benefits.
• Interprets data from clinical trials and reviews how they impact the continued conduct of a trial and the design of other clinical trials in the development plan.
• Involved in multi-disciplinary team decision-making.
• Contributes to interactions with regulatory authorities and research ethics committees.
• Able to manage projects including their planning, budgets, timelines, efficiency assessments and quality improvement activities.

Specialty Specific CiP 5

• Contributes to the authorship/ review of a Clinical Development Plan (CDP).
• Applies the principles of Good Clinical Practice (GCP), other relevant GxPs and regulatory requirements.
• Utilises quality management systems for the conduct of clinical studies.
• Able to oversee the conduct of clinical studies.
• Identifies, manages and mitigates risk in special populations.
• Contributes to the review and adaptation of study specific documents.
• Contributes to project management strategies.
• Able to interpret the results of clinical studies and contribute to authorship/review of Clinical Study Reports (CSR).

Specialty Specific CiP 6

• Knows the requirements for reporting adverse events and demonstrates an ability to report adverse events and perform a causality assessment.
• Designs and executes methods to monitor and assess safety data and to carry out continuous safety monitoring.
• Analyses and summarises safety data from all sources; presents conclusions.
• Performs a benefit-risk evaluation; able to identify if new information will alter the benefit-risk balance and effect the safety of patients.
• Identifies and manages risks to guide appropriate use of a medical product.
• Communicates new safety findings effectively and recommends appropriate risk management strategies and risk minimisation activities.
• Locates safety information associated with a medical product and provides advice on its safe and effective use.

Specialty Specific CiP 7

• Uses the benefit-risk evaluation of a medical product to perform a patient, product or product development impact assessment.
• Applies statistical principles including quantitative and relevant qualitative methods to reach conclusions in benefit-risk evaluation.
• Applies assessments of benefit-risk balance to reach milestone decisions in product development.
• Provides clear explanation of the benefits and risks of a medical product to enable appropriate patient engagement.
• Proposes product management strategies and risk mitigation.

Specialty Specific CiP 8

• Works as part of a team in creating the Target Product Profile and designing the Clinical Development Plan by providing medical and clinical input within the context of the business development plan and commercial feasibility.
• Provides a medical contribution to due diligence with respect to product profiling, positioning within the market and addressing unmet medical needs.
• Identifies the possible position in the portfolio for products in development or during in-licensing.
• Involved in medical product lifecycle planning and management.
• Demonstrates an ability to facilitate business decision-making during the development and lifecycle of the medical product.

Generic CiP 9

• Trusted to act honestly, openly and with integrity when interacting with patients, clinical trial participants, colleagues and other stakeholders.
• Able to recognise and practise within the limits of own professional competence and knows when to seek advice.
• Works within legal and regulatory standards and requirements.
• Applies the principles of equality and diversity in all professional interactions.
• Ensure that ethical considerations are paramount in medical practice and gain advice when dealing with conflicting ethical challenges.
• In all communications apply medical, regulatory, and professional standards, as recognised in the biopharmaceutical industry codes of practice.
• Recognises the privacy of any patient information they receive and ensures that patient confidentiality is maintained.
• Able to handle, store and transmit records containing personal information in line with data protection requirements.

Generic CiP 10

• Maintains accountability to the organisation for the scope of their role and for working within the appropriate medical/governance framework.
• Understands the structure and organisation of the pharmaceutical industry in the context of the production and provision of medicines and medical products for the benefit of patients.
• Demonstrates appropriate professional values and behaviours in performing the role of a pharmaceutical physician.
• Understands the organisation, accountabilities and responsibilities of national and regional regulatory agencies and related bodies.
• Understands the structure and organisation of relevant healthcare systems, e.g. the National Health Service (NHS) and related health organisations, e.g. National Institute for Health and Care Excellence (NICE).
• Always performs within regulatory and professional guidelines and codes of practice.
• Understands the legislative framework that the pharmaceutical industry operates in; keeps up to date with legal and regulatory developments and applies these in practice.
• Applies management and team-working skills, managing time and resources effectively.
• Demonstrates cultural and social awareness through appropriate situational sensitivities.

Generic CiP 11

• Adapts to the dynamic environment of pharmaceutical medicine and the need to anticipate changes and remain up to date.
• Critically appraises emerging trends and technologies in pharmaceutical medicine.
• Demonstrates an aptitude for life-long learning, taking ownership of their personal development plan, identifying gaps, and seeking continuing professional development activities to address these.
• Able to receive and respond to constructive feedback.
• Reflects on and learns from their professional practice and that of others.

Generic CiP 12

• Demonstrates applied knowledge and competence in leadership, teaching and mentoring relevant to the practice of pharmaceutical medicine.
• Ensures that the knowledge, skills, and behaviours associated with the competent practice of pharmaceutical medicine are communicated effectively and acquires the best techniques and practices to achieve this.
• Demonstrates leadership in applying knowledge to decision-making in teams.
• Demonstrates leadership in applying knowledge to educate and develop the capabilities of others.
• Contributes to teaching and training colleagues, including other healthcare professionals and other professionals e.g. scientists.
• Takes on a mentoring role for doctors in training and other colleagues.
• Where possible, supports colleagues who have problems with their performance or health and take appropriate action, including action plan development.
• Appraises and assesses learning outcomes honestly and objectively.
• Supports, mentors and/or supervises colleagues, trainees and/or direct reports appropriately, including using relevant feedback tools, so that they can learn in a risk-managed environment.

Generic CiP 13

• Contributes to the quality assurance of standards in clinical research.
• Facilitates regular reviews and audit of work activities and responding constructively to the outcomes.
• Identifies need for root cause analysis of problems and delivers amended processes where necessary.
• Able to provide further training if appropriate.
• Demonstrates engagement in feedback from patients, patient organisations, colleagues, healthcare professionals, regulatory.
• Participates in quality improvement activities

Generic CiP 14

• Shows respect for patients and treats them fairly and without discrimination; recognises and respects diversity in others; considers the needs of special populations and, where appropriate, ensures that they are not excluded from clinical research.
• Communicate information clearly, considering the audience that will be receiving it.
• Recognises the contribution of patients and clinical trial participants; works in partnership with patients/patient advocates in the interests of public health.
• Contributes to and complies with systems to protect patients, taking prompt action when patient safety may be compromised.
• Protects patients and colleagues from any risk posed by own health.

Currency Window

Evidence which demonstrates that you have met a curriculum outcome can be drawn from any point in your career. However, there should be corresponding evidence of recent (within the last five years of clinical practice (WTE)) to confirm the maintenance of the skill or competency. Evidence of your recent practice will be given more weight to reflect current capabilities and we suggest that approximately 50% of your evidence for a curriculum outcome is drawn from within the last five years of clinical practice (WTE).

Evidence Volume

around 100 electronically uploaded documents