Quality management in the area of drug approval (regulatory affairs) and statistics
Free of cost
by funding
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Certificates: Statistics" certificate
Certificate "Quality management in the area of drug approval (regulatory affairs)" -
Examination: Practical project work with final presentations
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Teaching Times: Full-timeMonday 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.)
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Language of Instruction: German
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Duration: 8 Weeks
Statistics
Statistical basics (approx. 6 days)
Measurement theory basics (population and sample, sample types, measurement and scale levels)
Univariate descriptive statistics (frequency distributions, central measures, measures of dispersion, standard value, histograms, bar charts, pie charts, line charts and box plots)
Bivariate descriptive statistics (measures of correlation, correlation coefficients, crosstabs, scatter plots and grouped bar charts)
Basics of inductive inferential statistics (probability distribution, normal distribution, mean value distribution, significance test, Fisher's null hypothesis test, effect size, parameter estimation, confidence intervals, error bar charts, power analyses and determining the optimum sample size)
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Methods for comparing two groups (approx. 5 days)
z- and t-test for a sample (deviation from a specified value)
t-test for the mean difference between two independent/connected samples
Testing the effectiveness of actions, measures, interventions and other changes with t-tests (pretest-posttest designs with two groups)
Supporting significance tests (Anderson-Darling test, Ryan-Joiner test, Levene test, Bonnet test, significance test for correlations)
Nonparametric methods (Wilcoxon test, sign test, Mann-Whitney test)
Contingency analyses (binomial test, Fisher's exact test, chi-square test, cross-tabulations with measures of association)
Methods for comparing the means of several groups (approx. 5 days)
One- and two-factorial analysis of variance (simple and balanced ANOVA)
Multi-factorial analysis of variance (general linear model)
Fixed, random, crossed and nested factors
Multiple comparison methods (Tukey-HSD, Dunnett, Hsu-MCB, Games-Howell)
Interaction analysis (analysis of interaction effects)
Selectivity and power analysis for variance analyses
Introduction to Design of Experiments (DoE) (approx. 1 day)
Full and partial factorial experimental designs
Project work (approx. 3 days)
To consolidate the content learned
Presentation of the project results
Regulatory Affairs: Quality management in the area of drug approval
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 this course, you will understand the basics of statistics, be able to process and evaluate data and present, explain and interpret statistical data analyses and results using graphics.
Furthermore, you are familiar with the guidelines, laws and standards relating to the approval of medicinal products. You are familiar with the requirements and procedures of the approval process and are able to take responsibility for the global 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).