Master's Degree in the Pharmaceutical and Parapharmaceutical Industry - Madrid
CESIF FORMACION S.L.Máster presencial
Madrid
Precio a consultar
Duración : 1 Año
European health regulations subject pharmaceutical companies to strict government controls in all areas of activity (research, development, registration, manufacture and marketing of pharmaceutical products and medical devices).
Similarly, gaining entry into the market for a therapeutic innovation requires a comprehensive understanding
of the regulatory landscape and norms in Spain, along with familiarity with the process of introducing the new
product.
The Master’s Degree in the Pharmaceutical and parapharmaceutical Industry has been created to:
- Aquire and develop specialised technical and scientific skills in the functional areas of the pharmaceutical and parapharmaceutical sectors.
- Instruct competent professionals to thrive in a constantly changing and complex global environment. By integrating into various fields of operation, professionals can pursue their goals of performance excellence.
- Boost the professional development of our students so they can occupy leading roles in the different pharmaceutical, biotechnological and medical device companies.
With this master’s programme, that has been recognised by the industry as a benchmark degree, CESIF consolidates academic and professional leadership in the sector. Furthermore, it is considered one of the best master’s programmes by the ranking of Best Master’s Degrees 2022 and 2023 of El Mundo.
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This program is designed for professionals who are seeking to get specialised in the pharmaceutical industry. It's meant fort individuals already working in the field, as well as recent graduates aspiring to pursue a career in the sector.
Temario completo de este curso
The master’s program comprises 10 modules, 9 focusing on specific aspects of the pharmaceutical industry and 1 devoted to the professional development. These modules are meticulously designed to cover a wide range of topics, including sector regulations and state of the art of the pharmaceutical industry.
The program excellently balances its technical core with soft skills training to prepare a 360 degrees professional. It will be delivered in English to ensure that participants are well-prepared for the global nature of the pharmaceutical industry.
The modules that build the master’s structure are the following ones including duration and main content:
- Pharmaceutical sector overarching view
- Types of companies in the pharma sector
- Organization of pharmaceutical companies
- Professional profiles in the pharmaceutical industry
- Business Development, Marketing, department functions,
- Regulatory, Medical Affairs, Manufacturing, Quality Control,
- Quality Assurance, Finances, etc
- Pharmaceutical technology introduction
- Qualified Person responsibilities
- Legal qualifications and licenses
- Traceability and distribution
- Medicines advertising/publicity regulations
- Export and importation of medicines
- End of module practical exercise
- Pharmaceutical Quality System
- Good Manufacturing Practices regulation
- Laboratory authorization by health authorities
inspection - ICH Q8. Pharmaceutical Development & Quality by
Design - ICH Q9. Risk Management
- ICH Q10. Pharmaceutical Quality System.
- ISO 9001 Quality System
- Personnel training and job descriptions.
- Documental Management
- Deviations, out of specifications and corrective/
preventive actions system - Complaints handling and batch recall management
- Quality audits and suppliers qualification
- Quality Continuous Improvement
- Good Distribution Practices
- End of module practical exercise
- Quality Control
- Good Laboratory Practices
- Laboratory areas design
- Pharmacopeias
- Retention and reference samples
- Investigation of out of specification results
- Stability studies
- Environmental control
- Microbiological laboratory
- End of module practical exercise
- Industrial Processes
- Manufacturing facilities design
- Facilities and equipment qualification
- Utilities qualification
- Manufacturing process validation
- Instrument calibrations
- Computer systems validation
- Solid forms manufacturing principles
- Liquid and semi-solid forms manufacturing principles
- Sterile manufacturing principles
- Cleaning validation
- Statistical Process Control
- Production Direction
- Integrated Production Planning
- End of module practical exercise
- Health Authorities relationship
- European Medicines Agency (EMA). Responsibilities and
organization - Spanish Medicines and Medical Devices Agency
(AEMPS) - United States Food and Drug Administration. Responsibilities and organization
- European Medicines Agency (EMA). Responsibilities and
- Regulatory Affairs
- Regulatory dossiers historic evolution
- Common Technical Documents (eCTD)
- Regional information in eCTD module 1
- Quality information in eCTD module 3
- Preclinical studies in eCTD module 4
- Clinical trials in eCTD module 5
- European medicines register system.
- Veterinary products
- Post-marketing activities
- Cosmetic products informative expedients and
cosmetovigilance - Medical Devices and Combination Products
- Commercialization and advertisement of medical
devices. - Dietary products
- End of module practical exercise
- Medicines Safety and pharmacovigilance
- Pharmacovigilance regulation
- Safety in Clinical Trials
- Side effects surveillance and reporting
- Aggregate reports (PSUR, ACO, DSUR)
- Veterinary pharmacovigilance
- End of module practical exercise
- Clinical Investigation
- Clinical Trials and Good Clinical Practices
- Design of Clinical Trials
- Clinical Trials monitoring
- Administrative management of Clinical Trials
- Activities and responsibilities of Medical Affairs
- End of module practical exercise
- Market Access and Pharmaeconomy
- Pricing
- Functions and responsibilities of Market Access
- Market Access strategy
- Economical assessment of health interventions
- Therapeutic market positioning
- Market Access planning
- Administrations relationship
- End of module practical exercise
- Professional Development
- Personal Branding
- Communication skills
- Teamwork, collaboration and time management
- Creativity and problem solving
Precio a consultar
9.500 € 9.000 €
12.970 €