Online Master's Degree in Industrial Pharmacy and Drug Registration
Madrid, Spain
Master degree
DURATION
1 year
LANGUAGES
Spanish
PACE
Full time
APPLICATION DEADLINE
EARLIEST START DATE
TUITION FEES
STUDY FORMAT
Distance Learning
Key Summary
The Online Master's Degree in Industrial Pharmacy and Drug Registration has been designed to offer students a comprehensive knowledge of the tools applicable to the design and development of Quality Systems, from the manufacturing to the release of drugs; as well as to give participants a complete, in-depth and practical view of the technical requirements to obtain marketing authorization for products with all health guarantees and in the shortest possible time.
In the pharmaceutical industry, drug supply chains are becoming more complex and globalized every day. At the same time, manufacturing requirements to ensure global supply and compliance with global safety, quality and control regulations make the incorporation of professionals with extensive knowledge of this field an essential requirement for companies in this sector.
Having professionals who provide up-to-date and in-depth knowledge of European and national health legislation is one of the main challenges for the registration departments (Regulatory Affairs) of companies in the sector.
This programme is therefore particularly interesting for professionals who wish to specialise in this field in order to access new professional opportunities or for professionals in the area who wish to specialise in order to take on new responsibilities.
- Practical and applied ONLINE methodology: The development of knowledge through active methodologies applied to online training models allows students to combine their studies with the rest of their professional and personal life obligations.
- Personalized monitoring: In addition to the teaching staff, students will have a group of tutors at their disposal who will personally monitor their progress, to guide the student at each stage and resolve any difficulties they may face during the course.
- Connection with the reality of the sector: Both the role of the Program Manager of the course, who has designed and directs its delivery, and the teaching faculty are made up of active professionals, guaranteeing the connection with the working reality of all students and the direct application of the knowledge they acquire during the course to their workplace.
Technical Sheet
General information
- Duration: equivalent to 60 ECTS
- Methodology: 100% online
- Duration: 1 academic year
- Continuous assessment of knowledge
Calls
Students have the opportunity to plan their training schedule together with their tutors. In this way, each future student can establish the time when the rest of their responsibilities will allow them to achieve the best academic performance and the time to apply the knowledge acquired during the course in their professional field.
Methodology
This Online Master's program is developed over 1 academic year.
During this period, 2 virtual classes will be activated per week and each student will have the possibility of requesting from their personal tutor the virtual tutorials they deem necessary to resolve any difficulty they may encounter during the study of content.
- 24/7 virtual campus: students can access it 24 hours a day, 7 days a week from any device with an Internet connection.
- Compatible with work and family life: each student decides where, when and how they want/can access the course content, taking into account the rest of the professional and family responsibilities that occupy their daily lives.
- Personalized advice: from the first moment to the end of the training process, students will be accompanied by qualified professionals who they can turn to to resolve any difficulties they may encounter.
- Constantly updated content: To ensure the highest quality of our training, our content is subject to continuous review and updating by our teaching staff, ensuring the direct application of the knowledge acquired during the course in the professional field.
The online Master's program in Industrial Pharmacy and Drug Registration is composed of the following topics:
Regulatory introduction
- Quality regulations in the pharmaceutical sector
- Role of quality.
- Types of pharmaceutical laboratories.
Quality assurance in production environments: quality control
- QC Functions according to the Regulations: Specifications, monographs.
- QC Functions according to regulations: stability studies.
- Validation of analytical methods/qualification of laboratory equipment.
- Introduction to cleaning validations.
Quality assurance in production environments: quality systems
- Quality assurance
- Quality systems
- Supplier management
- Audits by regulatory agencies.
- Quality systems: risk management. Tools.
- Quality systems (failure management): Complaints / Adverse effects / Returns / Market withdrawals.
- Quality systems (failure management): Deviations / Investigations / LAYERS / Escalations.
- Design of staff training and qualification plans. On-the-job training.
Quality assurance in production environments: pharmaceutical processes
- What is a pharmaceutical process?
- Equipment qualification.
- Facilities qualification: HVAC, water system.
- Validation of solid form processes.
- Process validation: soft gelatin capsule.
- Validation of manufacturing processes for liquid and semi-solid forms
- Sterile product validations.
- Validation of computer systems.
Quality assurance in non-production environments: marketing laboratories
- Good distribution practices. GDP audits. New regulations. Pharmaceutical warehouses.
- Quality systems for marketing laboratories. GMP and GDP audits.
- Virtual manufacturing site (External Quality): Third-party manufacturing. Quality in contract manufacturers. Own product vs. In licensing. Technical agreements: partner, manufacturer/releaser. Alignment of Quality systems with the third party.
Introduction to drug registration
- Legislation applicable to the registration of medicines.
- Functions of the Registration Department.
- Structure and organization of health authorities
- Types of medicines and dispensing conditions.
- Phases of drug registration
Registration dossier
- e-AF
- e-CTD
- Tools applied to drug registration.
- XEVMPD - Eudravigilance
- DMF
- Labelling of medicines and telematic management of technical sheets and leaflets
- Drug advertising.
Types of registration procedures
- Types of registration procedure. National procedure.
Other regulatory activities
- Record variations.
- Five-year renewal.
- Export and Import of medicines.
- Authorization to open pharmaceutical laboratories and its modifications.
- Drug prices and financing.
Registration of other legal bases: Medical devices, food supplements, cosmetics, personal care products.
- Medical devices.
- Food supplements.
- Cosmetics / Personal care products.
The Online Master's Degree in Industrial Pharmacy and Drug Registration is designed to develop the student's professional skills and abilities to the maximum in the following areas of specialization and fields of activity:
- Records departments in laboratories.
- Own manufacturing and marketing.
- Consulting and advice.
- Raw material suppliers.
- Manufacture to third parties.
- Import of cosmetics.
- Physical-chemical and microbiological analysis and control.
- Efficacy tests.
- Marketers.
Students will have acquired solid specialized knowledge that will allow them to achieve professional career development within the following industrial departments at national and international level:
- QA.
- Regulatory and safety of cosmetics.
- Manufacturing.
- Purchases.
- R&D.
- Commercial technicians.
- Others.