Master's Degree in the Pharmaceutical and Parapharmaceutical Industry - Barcelona
Master
En Barcelona
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Descripción
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Tipología
Master
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Idiomas
Inglés
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Lugar
Barcelona
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Duración
1 Año
This Master’s Degree in the Pharmaceutical and parapharmaceutical Industry is designed to:
- Offer solid specialised technical and scientific training for professional development in the functional areas of the pharmaceutical and parapharmaceutical sectors.
- Prepare competent professionals to thrive in a progressively challenging and intricate global environment. By seamlessly integrating into various fields of operation, professionals can pursue their goals of performance and operational excellence.
- Accelerate the professional career and development of our students on their way to occupying leading roles in the different pharmaceutical, biotechnological and medical device companies.
With this master’s programme, widely recognised by the industry as a benchmark degree, CESIF consolidates academic and professional leadership in the pharmaceutical sector. In addition, it is considered one of the best master’s programmes by the ranking of Best Master’s Degrees 2022 and 2023 of El Mundo.
Instalaciones y fechas
Ubicación
Inicio
Inicio
A tener en cuenta
This program is mainly tailored for professionals seeking to advance their careers within the pharmaceutical industry. It caters to individuals already working in the field, as well as recent graduates aspiring to pursue a career in pharmaceuticals. The program is designed to meet the diverse needs of professionals within this dynamic and highly regulated sector.
Students who successfully complete the Master’s Degree
(resolution and delivery of all the practical cases proposed and completion of the Final Master’s Degree Project with pass mark) will receive the corresponding diploma of the Master’s Degree in the Pharmaceutical and Parapharmaceutical Industry of CESIF.
- Practical “Learning by doing” methodology: Through case studies (design and implementation of clinical trials, follow-up and supervision of studies, financing and closure of trials, scientific communication, data management, etc.) and lectures by relevant speakers in the field, students engage with the industry’s dynamics and are able to apply the knowledge gained to the reality of the pharmaceutical sector.
- Tutorials and personalised guidance: Throughout the course, students will have the support of the teaching staff, made up of active professionals with extensive practical experience, and academic coordinators.
Students who so wish may pursue an internship in international companies from related sectors, in accordance
with the guidelines of the current regulations and in areas directly applicable to the contents of the master’s
programme.
The Career Services department manages the internship programme through direct relationships with the
business world.
Each student is offered personalised guidance and treatment so that they can choose the opportunity that best suits their profile.
Any financial remuneration of the internship will depend on each company’s standards.
Within the pharmaceutical industry there is a wide variety of professional roles:
- Regulatory and compliance: ensuring that products comply with current regulations and legal requirements.
- Pharmacovigilance: monitoring and assessing the safety of medicines and medical devices on the market, coordinating with stakeholders to report adverse events.
- Research and development: contributing to the research and development of new medicines and medical devices and working in laboratories and multidisciplinary teams to develop innovative products.
- Quality and assurance: ensuring compliance with quality standards in the manufacture and distribution of products.
- Marketing and sales: developing marketing and sales strategies to promote and market pharmaceutical and parapharmaceutical products, both nationally and internationally.
- Business development: identifying market trends and establishing strategic alliances for company growth.
- Consultancy: advising companies in areas such as regulation, marketing, quality and business development
in the health sector.
- Project management: leading initiatives from research and development to marketing and distribution of products.
Opiniones
Materias
- Pharmaceutical industry
- Business development
- Medicines advertising
- Export and importation
- Quality control
- Industrial processes
- Health Authorities
- Regulatory affairs
Temario
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
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Master's Degree in the Pharmaceutical and Parapharmaceutical Industry - Barcelona