Regulatory Affairs (quality management in the area of drug approval) with business English
Free of cost
by funding
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Certificates: Certificate "Quality management in the area of drug approval (regulatory affairs)"
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Additional Certificates: TOEIC® certificate (Test of English for International Communication)
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Examination: Practical project work with final presentations
TOEIC®-Test (Test of English for International Communication) -
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
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
Business English
General language part (approx. 4 days)
Basic structures of the English language
Tenses (simple, continuous, perfect), questions
Active/passive voice
Adjective/adverb
Modal verbs
Conditional
British and American English
Important idioms
Presenting in English
Communicative part (approx. 5 days)
Establishing and maintaining customer contacts, telephone calls, correspondence
Presentation of business visits
Dealing with complaints
Describing products
Writing letters and emails using common phrases on topics such as orders, quotations
Communicating the hierarchical structure of the company
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Business English (approx. 6 days)
Writing business correspondence
Influencing
Professional discussion of topics such as company structure, marketing and sales
Reporting on market analyses, discussion of financial trends
On a business trip: At the reception, in the hotel, in the restaurant
Appearance in meetings
Describing processes and procedures
Conducting negotiations and reaching agreements
Developing and communicating plans/projects
Preparing presentations
English-language job descriptions
Anglo-Saxon application process
Writing the CV
Interview: confident presentation of experience and qualifications
Project work, certification preparation and TOEIC® certification exam (approx. 5 days)
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.
You will also improve your English language skills in a practical way so that you can be successful in the international workplace. The course concludes with the internationally recognized TOEIC® test, which provides you with the best possible proof of your acquired knowledge.
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.
The informative TOEIC® test gives you a detailed insight into the language skills you have acquired, making it easier for you to enter and advance in your career.
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).