Quality management in the area of drug approval (Regulatory Affairs)

Free of cost

by funding

The course will familiarize you with the guidelines for the approval of medicinal products. You will be familiar with the requirements of the approval process and will be able to take responsibility for the approval of medicinal products. You will learn how artificial intelligence (AI) is used in your profession.
  • Certificates: Certificate "Quality management in the area of drug approval (regulatory affairs)"
  • Examination: Practical project work with final presentations
  • Teaching Times: Full-time
    Monday to Friday from 8:30 a.m. to 3:35 p.m. (in weeks with public holidays from 8:30 a.m. to 5:10 p.m.)
  • Language of Instruction: German
  • Duration: 4 Weeks

Introduction to pharmaceutical law (approx. 3 days)

Current legal framework for medicinal products (AMG, EU Regulation 726/2004 with reference to Directive 2001/83/EC)

Life cycle management

Pharmacovigilance

Paediatric Regulation


Regulatory authorities and institutions involved (approx. 2 days)

Federal Institute for Drugs and Medical Devices (BfArM)

Paul Ehrlich Institute (PEI)

Institute for Quality and Efficiency in Health Care (IQWiG)

Federal Joint Committee (G-BA)


Artificial intelligence (AI) in the work process

Presentation of specific AI technologies

and possible applications in the professional environment


European Medicines Agency European Medicines Agency (EMA)Marketing authorization dossier - Common Technical Document (CTD) (approx. 5 days)

Administrative Information

Overview and summaries

Pharmaceutical quality

Preclinical studies

Clinical studies


Preparation of an application for admission (approx. 2 days)

Medical Writing

Guidelines

Guidelines in the regulatory area

Notice to Applicants (NtA)

Scientific Advice (SA)


Types of approval (approx. 2 days)

National admission procedure

The central admission procedure

Mutual Recognition Procedure (MRP)

Decentralized procedure

Generics approvals

Authorization of biosimilars

Medicinal products for rare diseases

Standard approvals


Life cycle of a medicinal product after market launch (approx. 3 days)

The spontaneous reporting system

The Periodic Safety Update Report (PSUR)

The Risk Management Plan (RMP)

Extension of the marketing authorization (renewal)


Project work (approx. 3 days)

To consolidate the content learned

Final presentation of the project results



Changes are possible. The course content is updated regularly.

After the course, you will be familiar with the guidelines, laws and standards relating to the approval of medicinal products. You will be familiar with the requirements and procedures of the approval process and will be able to take responsibility for the worldwide approval of medicinal products.

The course is aimed at people with a degree in (veterinary) medicine, biology, chemistry, pharmacy or a natural science course.

Employees in Regulatory Affairs Management in drug approval have a wide range of responsibilities: they are not only responsible for the support of a drug beyond its approval, but also coordinate all departments involved in its development and marketing to ensure the safety, quality and efficacy of the product as well as compliance with country-specific approval standards. Regulatory affairs management is essential for drug approval, which is why employees in this field are in high demand, especially in the pharmaceutical industry.

Your meaningful certificate provides a detailed insight into the qualifications you have acquired and improves your career prospects.

Didactic concept

Your lecturers are highly qualified both professionally and didactically and will teach you from the first to the last day (no self-study system).

You will learn in effective small groups. The courses usually consist of 6 to 25 participants. The general lessons are supplemented by numerous practical exercises in all course modules. The practice phase is an important part of the course, as it is during this time that you process what you have just learned and gain confidence and routine in its application. The final section of the course involves a project, a case study or a final exam.

 

Virtual classroom alfaview®

Lessons take place using modern alfaview® video technology - either from the comfort of your own home or at our premises at Bildungszentrum. The entire course can see each other face-to-face via alfaview®, communicate with each other in lip-sync voice quality and work on joint projects. Of course, you can also see and talk to your connected trainers live at any time and you will be taught by your lecturers in real time for the entire duration of the course. The lessons are not e-learning, but real live face-to-face lessons via video technology.

 

The courses at alfatraining are funded by Agentur für Arbeit and are certified in accordance with the AZAV approval regulation. When submitting a Bildungsgutscheinor Aktivierungs- und Vermittlungsgutschein, the entire course costs are usually covered by your funding body.
Funding is also possible via Europäischen Sozialfonds (ESF), Deutsche Rentenversicherung (DRV) or regional funding programs. As a regular soldier, you have the option of attending further training courses via Berufsförderungsdienst (BFD). Companies can also have their employees qualified via funding from Agentur für Arbeit (Qualifizierungschancengesetz).

We will gladly advise you free of charge. 0800 3456-500 Mon. - Fri. from 8 am to 5 pm
free of charge from all German networks.
Contact
We will gladly advise you free of charge. 0800 3456-500 Mon. - Fri. from 8 am to 5 pm free of charge from all German networks.