Online Course for Professional Experts in Drug Registration and Regulatory Affairs
Madrid, Spain
Course
DURATION
6 months
LANGUAGES
Spanish
PACE
Full time
APPLICATION DEADLINE
EARLIEST START DATE
TUITION FEES
STUDY FORMAT
Distance Learning
Key Summary
The Online Professional Expert Course in Drug Registration and Regulatory Affairs has been designed to provide students with a complete, in-depth and practical overview of all aspects related to the regulations applicable to drug registration, both nationally and internationally.
Participants will acquire the necessary knowledge to understand the technical requirements to obtain marketing authorization for products with all health guarantees and in the shortest possible time.
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 Regulatory Affairs departments 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: 6 months
- Equivalence: 30 ECTS
- Methodology: 100% online
- 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 plan 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 issue that may arise.
- 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 program of the Online Course for Professional Experts in Drug Registration and Regulatory Affairs is structured in the following content blocks:
Introduction to the Registry
The content of this first block forms the basis of the course program and mastery of the topics that structure it is essential to acquire the rest of the knowledge developed during the course. It is structured in the following sections:
- Legislation applicable to the registration of medicines.
- Functions of the registration department.
- Structure and organization of health authorities: Spanish Agency for Medicines and Health Products (AEMPS), European Medicines Agency (EMA) and Food & Drug Administration (FDA).
- Types of medicines and dispensing conditions.
- Phases for drug registration.
With this module, the student will acquire knowledge in:
- Pharmaceutical legislation applied to registrations / Regulatory Affairs, both at national and international level.
- The role of the records department within a pharmaceutical company.
- Health authorities involved in the evaluation and authorization of medicines.
- Steps to follow to obtain authorization for a medicine.
- Regulatory differences between generic drugs, innovative drugs, traditional herbal drugs, etc. Prescription-only drugs. Non-prescription drugs. Drugs excluded from funding (EXO). Complete dossier, bibliography, well-established use, etc.
Registration Dossier
During this block of content, important aspects such as the preparation of all the necessary documentation to obtain authorization for medicines, preparation of technical sheets, leaflets and labeling, computer tools used with health authorities for the presentation and sending of documentation and advertising are analyzed in detail.
It is structured as follows:
- Preparation of the Electronic Application Form (e-AF).
- Preparation of electronic files: eCTD (Electronic Common Technical Document) and/or NeeS (Non-eCTD Electronic Submissions).
- Computer tools applied to drug registration: RAEFAR II, CESP, CIMA, Labofar, IDMP, etc.
- Extended Medicinal Product Dictionary (XEVMPD): Eudravigilance.
- Drug Master File (DMF) / CEP: Open, closed part. Access letter.
- Labelling of medicines and telematic management of technical sheets and leaflets.
- Advertising of medicines / health products / food supplements and cosmetics.
With this module, the student will acquire knowledge in:
- Preparation of the drug registration dossier. eCTD (Electronic Common Technical Document) and/or NeeS (Non-eCTD Electronic Submissions).
- Preparation of the Electronic Application Form (e-AF): administrative data.
- Technical documentation of active ingredients. Drug Master File: Open and closed parts. Access letter.
- Management of the databases/computer tools necessary for the presentation and sending of documentation to health authorities.
- Introduction of drug information and its corresponding update in the European Medicines Agency (EMA) Medicines Dictionary.
- Preparation of technical data sheets, package inserts and labelling of medicines. Online management of technical data sheets and package inserts during the authorisation process for a new medicine and during changes to the marketing authorisation that entail a modification of the texts.
- Requirements for advertising medicines and other legal bases: Administrative procedures with the Autonomous Communities.
Types of Records Procedures
The third block goes into detail about the types of procedures that exist to obtain authorization for medicines.
- National procedure.
- Decentralized procedure / mutual recognition.
- Centralized procedure.
With this module, the student will learn to:
- Obtain authorization for the marketing of medicines by national procedure.
- Obtain authorization for the marketing of medicines through European procedures: mutual, decentralized and centralized recognition.
Other Regulatory Activities
During this block, the regulatory activities carried out in the Registries/Regulatory Affairs department for the maintenance and updating of the authorizations of authorized medicines will be analyzed.
- Record variations.
- Five-year renewal. Cancellation of a marketing authorisation. Temporary suspension. Request for free samples. Notifications on the marketing of medicines for human use. Application for a pharmaceutical product certificate.
- Export and import of medicines.
- Authorization to open pharmaceutical laboratories and its modifications.
- Drug prices and financing.
With this module the student will acquire the following skills:
- Update of drug authorisations. Registration variations.
- Other important regulatory procedures for the maintenance of authorizations.
- How to request authorization to open a licensed, manufacturing or imported laboratory and how to manage it with the health authorities.
- Procedures for importing, exporting and obtaining drug certificates.
- Processing of procedures for financing and setting prices for medicines by the national health system. Telematic application of the Ministry of Health: Gesfarma. Reference prices. Homogeneous groups.
Other Legal Bases
This last section addresses other legal bases that are managed in the registration departments of laboratories applied to health products, food supplements, cosmetics and personal care products.
- Medical devices.
- Food supplements.
- Cosmetics and personal care products.
With this fifth block, the student will know in depth the following requirements:
- For medical devices: product dossier. Distribution and manufacturing of medical devices. Obtaining the CE marking. Market surveillance. Labelling of medical devices.
- For food supplements: notification of placing on the market. Health registration. Authorization of facilities. Labeling of food supplements.
- For cosmetics and personal care products: notification of placing cosmetics on the market in the CPNP. Labelling of cosmetics. Application for national code. Application for free sale certificate (clv).
The Online Professional Expert Course in Drug Registration and Regulatory Affairs has been designed to develop the student's professional skills and abilities to the maximum in the following areas of specialization, both theoretical and practical, related to the Registration/Regulatory Affairs Departments of pharmaceutical companies at an international level.
The sectors of activity include:
- Pharmaceutical laboratories.
- Health sector consultancies.
- Health product companies.
The functional areas of development include:
- records.
- Validations / Revalidations.
- Regulatory Affairs.