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TRAINING SOLUTIONS Pharmaceuticals | Healthcare INTRODUCTION
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Training & field days are good for
THE OFFICE: TRAINING DAY “To fend off the increasing staff disillusionment a Training Day has been scheduled.”
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A.
Socializing
B.
Networking
C.
Challenging existing pecking order
D.
Improving gender relations
E.
All of the above.
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Confirm you read and understood all 258 SOPs
2/2/2018
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New projects in the pipeline New technology & systems Change in requirements New people on board New laws, regulations, policies Skills-job mismatch Relocation of operations Reorganization Mergers & acquisitions Business expansion Internal or external evaluation, audit 07/FEB/2018
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Geography
in pharmaceutical industry
HQ: USA, Japan, UK, Western Europe Major markets: USA, Europe, Japan, China Manufacturing: India and China Advanced manufacturing: USA, Japan, EU Clinical trials: USA, UK, Europe Complex services: USA, UK, Western Europe Low-cost services: India, Eastern Europe
Consolidation | Globalization | Outsourcing
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Industry reality
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Geographical divide between functions
Difficult transition between functions
Long distances, geopolitical hotspots
Over-specialization
Qualified staff shortage
Complex information sharing processes
Information shared globally (PHI, IP)
Lean operations
Single-source supply chain
Limited number of qualifying vendors
Vulnerable to disruption
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Industry reality
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• Increasing complexity of clinical research enterprise • Increasing cost of drug development • New technologies in drug discovery, drug development and drug safety
• High demand for experienced Clinical Research Associates • Minimum demand for entry level clinical research professionals
Bottlenecks in clinical research:
• Protocol amendments • Contract, budget, IRB approvals • Patient recruitment
• … and shortage of qualified workforce Years of experience for all staff often demanded by research sponsors 07/FEB/2018
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The clinical research enterprise would benefit from systematic training of available workforce
There is no shortage of talented people who have the necessary background in scientific and clinical disciplines, willing to learn to pursue a career in research.
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Adult training in corporate environment HIGH QUALITY INTERNAL TRAINING IS AN ESSENTIAL COMPONENT OF QUALITY MANAGEMENT
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Consequences Over-specialization Talent
acquisition
Talented people seek environments where they can grow. Personnel
No time | No resources | No incentives No career development path Time on the job in lieu of training Peer-to-peer knowledge transfer only 07/FEB/2018
retention
Professional development is an important motivator in healthcare Quality Failure
and efficiency lapses
to adapt and innovate
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SAT provides a process to determine WHAT
Performance-based, criterion-referenced instruction
to train
WHERE WHEN
to train
to train
HOW
to train
WHO
to train
HOW
WELL we trained
Transfer from training to the job
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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 assess how well the outcomes meet the specified needs.
Implement
Develop Design
Analyze 07/FEB/2018
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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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