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TRAINING SOLUTIONS Pharmaceuticals | Healthcare PART I – ANALYSIS
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Systems Approach to Training Evaluate
Flexible, outcome-oriented system
Instructional system shall determine needs and priorities, develop effective and effective solutions to achieving these needs, implement them competently, and asses how well the outcomes meet the specified needs.
Implement
Develop Design Analyze 07/FEB/2018
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Front-End Analysis to collect, collate and report job performance data
ANALYZE New laws and standards
Define tasks
New policies, requirements
•
Task is a job behavior
•
Subject Matter Expert Conference
New technology, systems
•
Logical & necessary unit
•
Participation of resident experts is critical
New projects, new people
•
Observable & measurable
List of tasks for instruction
Mergers & Acquisitions
•
Specific result
• •
Set of training standards
•
Conditions, standards & performance steps
•
Instructional setting
•
Resource requirements
Business expansion Organizational changes Evaluations, audit
Job Analysis What are the job requirements? Training standards
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Organizational roles & responsibilities
Prerequisite skills, ability Conditions and standards Performance steps
Task Analysis What are the tasks required to perform the job?
Requirements & Responsibilities What are the R&Rs of each element in the training establishment?
Task inventory
Task list & Individual training standards
Target population description
Instructional setting
Performance criteria
Corporate Training Manual Train the trainer program
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Job analysis
Requirements
REPORT: Front-End Analysis (what the job entails) ďƒ Verified list of all duties and tasks performed n the job ďƒ Which tasks have to be taught in a formal school (certification)
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New technologies/systems
Organizational changes New regulations Evaluations, audits Business needs 4
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New regulations, laws, guidelines and policies Priorities Roles
redefined
and Responsibilities
Knowledge Feedback New
transfer
from audits
technologies
Redesigned Proactive
processes
adaptation
Transfer
of new requirements in company policies and SOPs Revised
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training manual 5
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NEW TECHNOLOGIES in CLINICAL RESEARCH and DRUG SAFETY
Big data platforms
Real-world data
Precision medicine
Bioinformatics
Pharmacogenomics
Gene sequencing
Artificial intelligence
Clinical grade wearables
Risk-based monitoring
Biomarker detection
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M&A New
business priorities
Program
re-evaluation
Reallocation Alignment
of resources
of processes
Reorganization Personnel New
turbulence
teams, expertise silos
Information Data
systems
migration
Motivation
for knowledge transfer
Peer-to-peer
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training not enough
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Task list development
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Verify task list for accuracy and completeness
Refine and consolidate task list
Identify tasks for formal instruction
Logical and necessary unit of work Observable & measurable result 1 action verb & 1 object Specific act Independent of other actions Specific beginning and ending Occur over a short period of time
Drug safety
Task criteria
Initial task list development
• Code case in MedDRA • Evaluate expectedness • Evaluate seriousness • Entry case in a database • Determine reportability • EudraVigilance reporting • Export line listing • Identify studies in PubMed • Pull studies from CT.gov 8
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Task analysis Define task list
Develop conditions and standards
Develop performance steps
Determine instruction setting
Write target population description
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How often is the task performed? How critical is it for the job? Is it a subset of collective tasks? Can the task be taught in the job?
What are the performance requirements? How long does it take to get it done? What are the prerequisite skills and knowledge? What behaviors distinguish good performers?
Drug safety
Task analysis
Difficulty, complexity
• Code case in MedDRA • Evaluate expectedness • Evaluate seriousness • Entry case in a database • Determine reportability • EudraVigilance reporting • Export line listing • Identify studies in PubMed • Pull studies from CT.gov 9
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Instructional setting
Entry level instruction
Formal learning program
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Managed Onthe Job Training
Task taught to standard during initial instruction
Computerbased instruction or simulation
Job aids or selfstudy packets
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Tasks taught as preliminary or introductory that require follow-on training on the job Tasks left to Managed On-the jobtraining
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OUTPUT Corporate Training Manual Target List
population description
of tasks for instruction
Individual
Training Standards
Conditions
& Performance steps
Instructional Roles
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setting
& Responsibilities, staffing
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ARETE-ZOE, as a consultancy, provides solutions to complex problems in the high stakes and high consequence environment of Global Pharmaceuticals, including clinical research, healthcare informatics, and public health. We blend established, Pharma sector methodologies, innovation, and adaptations/transfers from other sectors to identify and resolve consequential practices that pose risk and often result in avoidable patient casualty. However, we are specifically, not a patient advocacy group but believe in optimizing organizational effectiveness and that smart business is agile, competitive and profitable, while intrinsically safe, secure, and resilient. We work within a global context because transnational interests influence national circumstances and choices at point of prescription. ARETE-ZOE, provides full spectrum organizational and operational risk management consultancy. Our published materials provide a glimpse of some aspects of our services to demonstrate both knowledge and ongoing participation within the Pharmaceutical Industry. Our analysis and consultancy includes all channels of misuse, diversion, counterfeiting and illicit exploitation of pharmaceuticals, medical devices, and precursor chemicals. Our advisement is to manufactures, jurisdictional entities, insurers, legislators, litigators, patients, and health care providers. This scope also frequently segues into the nexus of crime and terrorism as significant influencers that undermine sector integrity differentiated from other criminal activity. Obviously, vulnerability assessment, information collection management and intelligence production supporting decision-making for risk reduction and interventions are routinely within the scope of our services as well as design and implementation of operational control measures.
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