Regulatory Affairs © © Paulista

Post Graduate Award in Regulatory Affairs

  • Flexible study concept with self-study and live webinars
  • Certificate with exam and 10 ECTS 

Regulatory Affairs covers the key regulatory and medical affairs issues affecting the industry today from an overview of the major drug regulators and the requirements during drug development to medical information and regulations including prescribing issues to life cycle management issues.

After successfully completing this course, students will be able to:
•    Evaluate the regulatory issues affecting the pharmaceutical industry
•    Compare the regulation of medicines in different global markets, specifically in the EU and MENSA area
•    Develop and critically appraise product-related information to ensure adherence to ethical and legal provisions.
•    Compare and evaluate the different roles of Regulatory and/or Medical Affairs departments to propose consistent strategies involving the marketing of pharmaceuticals, medical information, the role of a pharmaceutical company’s country medical department and licensing agreements.

Learning Aims and Objectives

The aim of this course is to provide a broad introduction to the profession and technical aspects of regulatory affairs, emphasizing the strategy and tactics used by regulatory affairs professionals. This during new drug development, from initial chemistry manufacturing and controls for the new drug substance and respective drug product to nonclinical and clinical trials development, through registration and application for market authorization of the new medicine with both US FDA and EU EMA.  International filings and post-marketing compliance are also covered emphasizing major markets such as Japan, China, and Brazil, as examples on how to seek approval for new medicines with regulatory authorities worldwide. 
The key learning objectives are a broad understanding, including pragmatic activities and roles for the regulatory professional, of the main topics covered in the course: 

  • Introduction to US and EU Regulatory Affairs 
  • Common Technical Document (CTD) for Regulatory Applications
  • Regulatory Intelligence and Strategy
  • Chemistry Manufacturing and Controls (CMC): Small Molecules and Biologicals   
  • Nonclinical Safety Regulatory Science
  • Clinical and Regulatory New Drug Development
  • Clinical Trial Applications (CTA) and Investigational New Drug (IND)
  • Scientific Advice Meetings with Regulatory Agencies
  • Filing and Approval of New Drugs/Medicines 
  • International Filings
  • Life Cycle Management

Format & Content

Format:

The course is delivered in 12 weeks over a period of 3 months.
The course is a blended programme of study using a combination of teaching methods which includes:
Live Webinars (30 hours)
E-learning (12 hours)
Self-directed learning and reflective practice (268 hours) 
The hours are an estimate of the time distribution and may vary in between weeks. 

The self-learning hours include not only reading the materials sent by instructor weekly but also researching sources (e.g. regulatory agencies websites) to answer questions and be prepared to discuss regulatory case studies at webinars. These hours also include significant time-commitment to research and reply in writing to the comprehensive final take-home examination.  

Content:

Week 1: Introduction to US and EU Regulatory Affairs
Aims of this Week:

  • Explain the overall roles of medicines agencies in the US and EU (plus UK) 
  • Distinguish between Accelerated and Standard Approval processes and timelines. 
  • Expain Orphan drug designations and approval
  • Expose students to the regulatory affair’s professional perspective of some well-known-cases of recent health authorities approvals such as the Covid-19 vaccines and medications for SARS-Cov-2, including in emergency use situations

At the end of the participants will be able to:

  • Describe basic FDA, EMA, EU National Authorities organization and procedures 
  • Understand how to integrate and accelerate the emergency use new medicine 
  • Explain what are FDA advisory committees, rolling reviews and why different agencies may come to different conclusions or different timelines for approval of new medicines  


Week 2:  Common Technical Document (CTD) for Regulatory Applications 
Aims of this Week:

  • Explain what is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and its guidelines including the ones related to CTD modules
  • Provide an overview and individual granularity discussion of the 5 modules of the CTD  
  • Introduce students to the concept of an electronic Investigational New Drug (IND) application in electronic CTD (eCTD) format in a cumulative manner

At the end of the Week the participants will be able to:

  • Understand main ICH guidelines including CTD guidelines and how they transpose to individual countries regulations 
  • Become familiar with Module 1 regional, Module 2 Summaries, Module 3 Quality, Module 4 Safety, Module 5 Clinical 
  • Understand that the CTD modules can be used both for the submission of the new drug registration worldwide as well as for the initiation of regulatory process in such geographies such as in the US FDA IND


Week 3: Regulatory Intelligence and Strategy 
Aims of this Week:

  • Explain the differences between laws, regulations, guidelines, scientific advice, precedents
  • Explain how to go about seeking for regulatory intelligence in US and EU related to your competitors or similar development programs, namely FDA SBAR (summary basis of approval) and EMA EPARs (European Public Assessment Reports)
  • Explain what a regulatory strategy global document is
  • Describe the need to plan studies well ahead of trial initiation and discuss them early with agencies to meet a desired Target Value Profile for the product’s label

At the end of the Week the participants will be able to:

  • Understand what regulatory intelligence is
  • Be able to search for precedents on new drug approvals – SBAR and EPAR
  • Understand how to initiate and put together regulatory strategy and planning 
  • Understand how to work with the project management and planning function to plan development programs up to registration and approval


Week 4: Chemistry Manufacturing and Controls (CMC): Small Molecules and Biologicals   
Aims of this Week:

  • Explain what is CMC and why is so heavily regulated 
  • Describe the main ICH Quality guidelines related to quality 
  • Explain CMC common and distinct requirements for small molecules and biologicals
  • Describe the basic CMC requirements that need to be fulfilled and improved from first in human trials to registration of a new chemical entity or biological Explain the Investigational Medicinal Product Dossier (IMDP) contents and purpose  

At the end of the Week the participant will be able to:

  • Become familiar with main ICH guidelines for quality  
  • Understand general CMC requirements in new drug development for both small molecules and biologicals 
  • Name the main sections of the IMPD


Week 5: Nonclinical Safety Regulatory Science 
Aims of this Week:

  • Describe the main ICH guidelines for nonclinical safety 
  • Explain how to apply the nonclinical safety guidelines in new drug development for both small molecules and biologicals 
  • Illustrate an integrated nonclinical program prior to different phases of human clinical trials 
  • Explain the primary purpose and overall design of the different types of nonclinical studies

At the end of the Week the participant will be able to:

  • Become familiar with ICH nonclinical safety  
  • Understand how to devise a nonclinical program prior to human exposure
  • Understand the objective and general design of several nonclinical studies 


Week 6:  Clinical and Regulatory New Drug Development 
Aims of this Week:

  • Explain First-in-Human Regulatory Issues (Nonclinical basis and Phase I clinical trials)
  • Explain Phase 2 and Phase 3 Clinical Regulatory Affairs - Clinical Protocols and Good Clinical Practices, including validation of endpoints 
  • Define what are Patient Reported Outcomes and Patient Centricity Drug Development 
  • Explain the importance of the Target Product (Value) Profile and respective Label desired once the product is approved 
  • Overview of efficacy power calculations requirements for patient numbers versus patient safety exposure requirements (ICH E1) 

At the end of the Week the participant will be able to:

  • Understand how to devise clinical protocols for different phases of human trials
  • Understand how to collaborate with clinicians for a successful new drug development plan and strategy, with the adequate number of patients and trials 
  • Become familiar with desired label based on the clinical trials data: US Package Insert and European SmPC


Week 7: Clinical Trial Applications (CTA) and Investigational New Drug (IND)
Aims of this Week:

  • Provide an overview of the formal processes to initiate clinical trials in both Europe, US and rest of the world, with both health authorities and ethics committees 
  • Explain what are Good Clinical Practices (GCP) 
  • Provide an overview of clinical trials documents necessary to conduct and conclude a trial from clinical trial protocol to clinical study report, including investigator’s brochure, protocol amendments, informed patient consent, safety documents   
  • Understand how to comply and respond to agency’s questions at the time of approval of a trial 

At the end of the Week the participant will be able to:

  • Understand and become familiar with how to initiate clinical trials and maintain them compliant with existing local regulations
  • Become familiar with the main documents necessary for a clinical trial and the concept of a core CTA for Clinical Research Organizations (CROs) working on behalf of a sponsor, Transfer of Obligations
  • Describe the differences between the European Clinical Trials Regulation and Directive versus the US IND process
  • Become familiar with how to respond to questions from agencies and ethics committees about the trial or trial initiation  


Week 8: Scientific Advice Meetings with Regulatory Agencies 
Aims of this Week:

  • Provide an overview of how to consult with regulatory agencies in US and EU for both adult indications and pediatric purposes such as US PSP and EU PIP, from pre IND to End of Phase 2 meeting, EOP3 and pre-filing meetings. 
  • Explain the meeting request and briefing document process for US FDA meetings with sponsors 
  • Explain the scientific consultation process with both EMA or European Health National Authorities from specific countries such as Germany’s BfArM, Sweeden’s MPA or Ireland’s HPRA  
  • Describe briefly the ability to seek joint/parallel scientific in EU with both regulators and payers in order to also discuss future pricing and reimbursement issues  

At the end of the Week the participant will be able to:

  • Understand and become familiar with the scientific advice processes in both US and EU, plus the parallel advice process 
  • Describe how to initiate, provide documentation, and conduct a meeting with US FDA or EU agencies, by liaising with the Regulatory Project Manager 
  • Become familiar with how to improve adult and pediatric plans based on early alignment of expectations with regulatory agencies 
  • Become aware of the need to integrate reimbursement thinking into regulatory advice and strategy 


Week 9:  Filing and Approval of New Drugs/Medicines 
Aims of this Week:

  • Explain Marketing Authorization Applications (MAA), New Drug Applications (NDA), and Biologics License Application (BLA) – processes and timelines 
  • Understand how scientific advice and all previous regulatory work described in the course so far feeds into registration and filing of new medicines

At the end of the Week the participant will be able to:

  • Describe main stages, processes and timelines for MAA, NDA and BLAs 
  • Become familiar with how to summarize all the regulatory development of a new medicine into filings for approval of a new drug via the CTD module 2 summaries and overall CTD, as well as final negotiations with regulatory agencies 


Week 10:  Post-approval and Marketing Regulatory Compliance 
Aims of this Week:

  • Discuss the requirements necessary to maintain a new medicine properly licensed once it is approved, licenses maintenance and fees  
  • Briefly point reimbursement and pricing issues and the gap between approval date and launch of a new medicine 
  • Explain how to handle regulatory wise any changes to an approved medicine, including the variations process
  • Discuss post marketing commitments such as additional safety data, risk management plans 
  • Discuss advertising differences and regulatory overview of advertising to patients (US only) or health care professionals (US, EU) 

At the end of the Week the participant will be able to:

  • Understand what variations to an approved application are and their different types (changes being affected, changes requiring prior approval, etc). 
  • Explain main types of post marketing commitments such as safety study extensions, pediatric commitments, risk management plans, 
  • Become familiar with advertising regulations for new medicines both in the US and EU  


Week 11:  International Filings
Aims of this Week:

  • Provide an overview of Japan and China regulatory process
  • Explain why Japan and China must have their own strategy (prior local clinical studies) in order to join global Phase 3 trials common to US  and EU as pivotal trials 
  • Provide an overview of Brazil and Australia regulatory processes as examples of intercontinental filings  
  • Explain what are Multi regional clinical trials and relevant ICH guidelines

At the end of the Week the participant will be able to:

  • Understand and become familiar with regulatory strategy not only for EU and US both also for those geographies like Japan and China that may require special local clinical requirements and studies during clinical development 
  • Become familiar with a worldwide regulatory strategy and registration plan

 
Week 12: Life Cycle Management 
Aims and Learning Outcomes

  • Use Life cycle management and filing of new indications and/or new dosage forms as an opportunity to Review key points in all areas above covered in the entire course regarding regulatory affairs. 

Learning Outcomes

On successful completion of this course a student will be expected to become familiar with the Regulatory Affairs profession in the Pharmaceutical and Biotech industry, ensuring that regulatory requirements (laws, regulations, guidelines, scientific advice, precedents) are followed and leveraged strategically to optimize new drug development. 

This is in all stages of such development such as manufacturing, analytical, pre-clinical, clinical testing, registration, approval, reimbursement, and commercialization of new medicines, either novel biologicals or new chemical entities (small molecules). 
 

Schedule of the live webinars & lectures

All live webinars are recorded and can be viewed again at any time and as often as you like. This means you can always watch the content of the webinar again afterwards at your leisure. In principle, all webinars are mandatory, but you can miss up to 3 webinars to be flexible. We recommend that you attend at all webinars, if possible, so that you can ask all your questions and take part in the discussions with the other participants.

Your benefits of the live webinars
✔ Flexible
✔ Location independent
✔ Participate live or watch the webinar later at your own leisure
✔ Ask your questions directly to the speaker
✔ Discussion with other participants

What's the difference between a webinar and a lecture?
Lecture: Lecture ist not interactive. The referant tape and/or post slides for the participants to consult in their own time.
Webinar: The Webinar is an interactive session at 6:30 PM CET where the referent present the highlights of the lecture material or additional material/practical case studies. The students have the opportunity to ask interactive questions.

Week

Topic

Title

Type

Duration (hours)

Date

Time (German time)

1

Introduction to US and EU Regulatory Affairs

FDA, EMA, EU National Authorities Overview  

Lecture

0.5

   

Flexible time management of the participant

1

Introduction to US and EU Regulatory Affairs

Orphan drug designations and expedited approvals;  Covid-19 vaccines example of  accelarated regulatory process

Lecture

0.5

    

Flexible time management of the participant

1

Introduction to US and EU Regulatory Affairs

Overview of next lectures. Questions and Answers regarding introduction to regulatory affairs 

Webinar

2.5

    17.03.2021

18.30

2

Common Technical Document (CTD) format for Regulatory Applications

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) 

Lecture

0.5

   

Flexible time management of the participant

2

Common Technical Document (CTD) format for Regulatory Applications

Main ICH guidelines inclunding the ones directly related to CTD 

Lecture

0.5

   

Flexible time management of the participant

2

Common Technical Document (CTD) format for Regulatory Applications

Overview of the 5 modules of the CTD 

Webinar

2.5

24.03.2021

18.30

3

Regulatory Intelligence and Strategy  

The differences between laws, regulations, guidelines, scientific advice, precedents

Lecture

0.5

   

Flexible time management of the participant

3

Regulatory Intelligence and Strategy  Exploring Regulatory Intelligence and Precedents from FDA and EMA 

Lecture

0.5

   

Flexible time management of the participant

3

Regulatory Intelligence and Strategy Regulatory Strategy and Planning 

Webinar

2.5

31.03.2021

18.30

4

Chemistry Manufacturing and Controls (CMC)  Regulatory  – Small molecules

What is CMC regulatory 

Lecture

0.5

   

Flexible time management of the participant

4

Chemistry Manufacturing and Controls (CMC)  Regulatory  – Small molecules

The Main ICH Quality Guidelines 

Lecture

0.5

   

Flexible time management of the participant

4

Chemistry Manufacturing and Controls (CMC)  Regulatory  – Small molecules

CMC regulatory for small molecules and biologicals 

Webinar

2.5

  07.04.2021

18.30

5

Nonclinical Safety  Regulatory Science

The ICH Nonclinical Safety Guidelines (fundamental for small molecules/new chemical entities) 

Lecture

0.5

   

Flexible time management of the participant

5

Nonclinical Safety  Regulatory Science

The ICH Nonclinical Safety Guidelines for Novel Biologics 

Lecture

0.5

   

Flexible time management of the participant

5

Nonclinical Safety  Regulatory Science

Overview of a Nonclinical Program Prior to Human Exposure and Prior to Registration 

Webinar

2.5

   14.04.2021

18.30

6

Clinical and Regulatory New Drug Development First-in-Human Regulatory (Nonclinical basis and Phase I clinical trials). TPP and Label goals for US PI and EU SmPC 

Lecture

0.5

   

Flexible time management of the participant

6

Clinical and Regulatory New Drug Development Phase 2 and Phase 3. Clinical Protocols and Good Clinical Practices. Efficacy and Safety Exposure Requirements. 

Lecture

0.5

   

Flexible time management of the participant

6

Clinical and Regulatory New Drug Development Validation of endpoints and patient reported outcomes plus patient centric drug development 

Webinar

2.5

  21.04.2021

18.30

7

Clinical Trials Applications (CTA) and Investigational New Drug Applications (IND)

Good Clinical Practices (ICH) and Overview of Main Regulatory Documents Necessary for a Clinical Trial 

Lecture

0.5

  

Flexible time management of the participant

7

Clinical Trials Applications (CTA) and Investigational New Drug Applications (IND)

Formal Processes to Initiate Clinical Trials and Maintain Them Compliant with Health Authorities/Ethics committees 

Lecture

0.5

  

Flexible time management of the participant

7

Clinical Trials Applications (CTA) and Investigational New Drug Applications (IND)

 European New Clinical Trials Regulation and US IND process

Webinar

2.5

 28.04.2021

18.30

8

Scientific Advice Meetings with Regulatory Agencies 

Meeting request and briefing document process with US FDA for sponsor meetings, for adults and pediatrics

Lecture

0.5

   

Flexible time management of the participant

8

Scientific Advice Meetings with Regulatory Agencies 

Consultation from EMA or other EU Health Authorities, for adults and pediatrics. Parallel Advice with Payers

Lecture

0.5

   

Flexible time management of the participant

8

Scientific Advice Meetings with Regulatory Agencies 

Overview of a consultation process in both US and EU and how to use it to align and improve your drug development

Webinar

2.5

  05.05.2021

18.30

9

Filing and Approval of New Drugs/Medicines 

Marketing Authorization Applications (MAA)

Lecture

0.5

   

Flexible time management of the participant

9

Filing and Approval of New Drugs/Medicines 

New Drug Applications (NDA)

Lecture

0.5

   

Flexible time management of the participant

9

Filing and Approval of New Drugs/Medicines 

Biologics License Application (BLA)

Webinar

2.5

   12.05.2021

18.30

10

Post-approval and marketing regulatory compliance

Post Marketing Commitments such as Risk Management Plans or Safety Study Extensions and Additional Data 

Lecture

0.5

   

Flexible time management of the participant

10

Post-approval and marketing regulatory compliance

Reimbursement and Health Technology Assessment. Variations to an Approved Application

Lecture

0.5

  

Flexible time management of the participant

10

Post-approval and marketing regulatory compliance

Advertising and Communication  Regulations for Patients (US only) and Health Care Professionals (US, EU)

Webinar

2.5

19.05.2021

18.30

11

International  Regulatory Filings Japan PMDA and China NMPA registrations 

Lecture

0.5

  

Flexible time management of the participant

11

International  Regulatory Filings Rest of the World Registration.  Brazil ANVISA and Australia TGA Examples. 

Lecture

0.5

  

Flexible time management of the participant

11

International  Regulatory Filings Questions and Answers 

Webinar

2.5

  26.05.2021

18.30

12

Life Cycle Management  of New Drug Indications New Indications 

Lecture

0.5

   

Flexible time management of the participant

12

Life Cycle Management

New formulations (New Dosage Forms)

Lecture

0.5

   

Flexible time management of the participant

12

Life Cycle Management

Questions and Answers.  Introduction to the written assignment 

Webinar

2.5

02.06.2021

18.30

As of February 2021, subject to change.

Your referent

Peter Caetano

A-Peter Caetano © SpringerCampusPeter Caetano is Ipsen's Global Regulatory Affairs Senior  Director in Oxford. He teaches at the College of Medicine and Dentistry, Univ. Ulster, N. Ireland.

Dr. Caetano is team leader for scientific advice and submissions worldwide for novel biologicals. he was EU Sr. reg. manager at Allergan, Latin America reg. manager at Genzyme-Sanofi, and US reg. manager at P&G. Caetano liaises with FDA, EMA, ANVISA, etc. bringing medicines to market. Peter authors BDs, INDs, CTAs, CTDs, BLAs, MAAs. He masters CMC, preclinical and clinical reg. strategy, with technical expertise in drug development ranging from pharmaceutical biotechnology to clinical endpoint validation. 

Peter holds a PhD from Michigan, PharmD from Ohio State, MPH from Harvard, PgDip from Oxford, and MBA from ESSEC-Mannheim.

Cooperation partner: College of medicine & dentistry, Birmingham (UK)

College of Medicine & Dentistry © College of Medicine & DentistryEstablished in 2018, we are one of the few private education providers offering a wide range of training programmes for the dental team and all healthcare professionals.  Working across a blended learning concept, we aim to reach out to all aspiring individuals to improve their knowledge and skills.  Our collaboration with Ulster University enables us to offer a wide range of career progression opportunities.

FAQ

Frequently Asked Questions

General questions

Is the course limited to a certain period of time? For example, that the course must be completed within 4 months?
 

We will deliver the course within its 3 months’ duration and the student has to finish the final exam within one week of receiving in the last week.  A second and only attempt will be possible in case the student fails that exam but that too will only be allowed within one week of receipt of the second exam.

Are there admission requirements for the course or can anyone interested participate?
 

Yes, we have admission requirements: A level 6 degree in Pharmacy, Biomedical science, Medicine or equivalent

What is the minimum number of participants for the course?

The minimum number of participants for the course is 5.
When do I have to pay the course price?

You do not have to pay the course price until you have been successfully admitted to the course. After your registration, our cooperation partner COMD will check all admission criteria and conduct the English test, if necessary. Only then, when you have successfully passed everything, you will you receive an invoice from COMD.
Is there also payment by instalments?
 

Yes, payment by instalments is possible. Please contact us in plenty of time if you would like to make use of this option. The instalment payment will then look like this: 30% in advance, 40% after 4 weeks of start, 30% after 8 weeks of start.

What happens after I have submitted my registration?

If you have submitted your registration via our Springer Campus page, you will first receive a confirmation of receipt. After that, a colleague will contact you by email and send you a registration form to fill out. We will then forward this completed and signed form to COMD.

Self-directed learning

Where will the self-directed learning take place?
 

The self-directed learning will take place on Moodle where materials will be available. You will get access by our cooperation partner COMD.

How it will be structured?

Every Monday, new materials are provided by the instructor on Moodle, which students should work through until the webinar on Wednesday. In this webinar, the materials are presented by the instructor and reviewed together with the participants. There will also be discussions and the opportunity to ask questions.
What materials will I get for learning?
 

The material will be pdf slides summarizing regulatory affairs experience of close to 20 years with recent cases studies and main highlights.

The self-directed learning of 268 hours will be based on video material or books?
 

In the slides that the instructor will send as well as weekly assignments. The instructor will recommend book chapters (not mandatory if student have no access to those), articles and most of all regulatory guidelines and summary basis of approvals packages, freely available from FDA, EMA, ICH or other agencies websites detailing how previously other drugs were approved.  Regulatory books are good for overview of issues, unfortunately they are very expensive. Thus the instructor doesn’t expect students to read them if not possible to have easy access to them. Thus, instructor will summarize main ideas, concepts and practical recommendations on slides, and direct students to guidelines, guidance and practical information available at no cost. The self-directed learning will be practical based on research required to establish new drug development programs that will lead to medicines approvals in CMC, nonclinical, and clinical.

Do I get free access to the books during the course or do I have to buy them themselves? Are the books necessary for the successful completion of the course?
 

Books are only recommended and not provided to students. The instructor understands that regulatory books are very expensive and of difficult access, so mandatory readings including for examinations will only be from freely available sources such as the FDA, EMA or ICH websites. 

How long can I access the course materials?

You can access the course material at any time during the course. You can also download it so that you can review content even months after the course.
Can the materials be downloaded?
 

Yes, you can download the material.

Will the slides of the power point presentations of the webinar be made available?
 

Yes, as PDF. However, the webinar is primarily the forum for students to interact with the instructor and for the instructor to present live the course materials for the week (no new materials specifically for the webinar) and answer to student questions about the material previously sent. So it is essential that students attend webinars and take notes.  

Can I always ask my questions to the referent?
 

The webinars are the time for you to ask questions about the material and see if you have really understand the course material.  The instructor is a very busy global regulatory affairs professional and will not be answering questions individually outside of those seminars.  Please make every effort to attend the webinars.

Live webinars

How will the webinar be structured? Will there be only one speaker talking about the content or will there also be tasks?
 

They are interactive webinars, with speaker presenting live content sent ahead in weekly materials and practical exercises/discussion of regulatory case studies. The success of the webinars will depend in large measure of the students curiosity, questions and participation based on the material that they have read for this week.

Who will hold the webinar?
 

The webinar will be held by Dr. Peter Caetano. For more information about the referent, please see "Your referent" above.

Is every webinar mandatory or is it up to the participant to decide whether or not to participate?

Webinars are mandatory. Students may miss at most 2-3 webinars or about 20%. The webinars are the time for the students to ask questions about the material and see if they really understand the course material. The instructor is a very busy global regulatory affairs professional and will not be answering questions individually outside of those seminars. So students should not miss the webinars and interact lively with one another and the instructor.
 

Hence, an effort to attend most if not all webinars should be required from the students.  The webinars will be mostly strengthen by students curiosity, interest, reflection about the materials shared previously, questions and discussion around specific cases studies of regulatory drug development.

Where will the webinar start? On which system?

All webinars will be imparted using Zoom or Microsoft Teams.
How do I get access to the webinar?
 

An email will be sent to you with the log in details prior to the webinars.

Are the webinars recorded?
 

All live webinars will be recorded and can be viewed again at any time and as often as you like.

Exam

Are there intermediate exams between the individual webinars?
 

Besides final exam which is the one which counts the most for the final grade, the instructor may also send smaller case studies in most weeks requiring brief answers (1-2 pages) and research regarding the topic of that week.

Is there an exam at the end of the course?
 

Yes, you will need to do a final exam.

How can I imagine the final exam?
 

This will be a take home written examination with a practical case study, based on real data and medicines approved or about to be approved by regulatory agencies.  The instructor may add also some fictional medicines in order to stimulate the students to place themselves in the role of regulatory professionals dealing with new investigational drugs, but those drugs will also be described in the context of similar medicines approved by regulatory agencies.  

What will the procedure be like?
 

In order to write the exam, the student will be required to perform research (e.g. summary basis of approval from FDA and European public assessment reports from EMA/EU national agencies)  and integrate of all the learnings from the previous weeks (e.g. from nonclinical to international filings). The answer to the final exam should be about 10 pages long, written clearly and in a succinct manner as if it was a regulatory strategy document to be shared with upper management of Pharma/Biotech.

When will I receive the tasks for the exam? How it will look like?
 

You will receive it in the final week of the course and will have one week to do it at home. It will be a series of questions on all topics discussed in the class (e.g. CMC, Nonclinical, and Clinical) based on one or more medicines approved or about to be approved.  Some medicines can be fictional, to prone the student to come up with their own regulatory strategy and thinking, but most if not all medicines will be real hence with research data available in regulatory agencies websites, company websites or clinical trial registries.

How do I hand in the exam then? Do I upload it to Moodle or do I send it directly to the lecturer by email?
 

Ideally the exam should be uploaded on moodle. Emailing of exams is a possibility only if moodle becomes to cumbersome to upload/download assignments. During the course, as the instructor is a very busy global senior regulatory affairs executive, he expects minimal email or moodle contact from students and will not reply to any such messages regularly. Students instead should bring all of their questions to the highly participative interactive weekly sessions with the instructor, where he will be available to answer questions directly. The instructor enjoys sharing his knowledge directly with students in an engaging and interactive conversation with students where we will look at all angles of a regulatory problem together, from soft aspects such as diplomacy or cultural issues when dealing with regulatory agencies to hard aspects such as statistical definition of primary endpoints for the purpose of regulatory approvals.

How long time will I have for the final exam?

One week. The final exam is a take home exam requiring research. Students have one week to write the 10 pages answer from date of receiving it on the final week. About 40 hours of the self-learning will be expected on researching and writing that exam.
Is it possible to give more than one week for the final exam in Regulatory Affairs?
 

Unfortunately, not, the final exam has to be written in one week.

How will it be graded, are there certain criteria or similar and who will grade it?
 

The instructor will assess it.  The criteria can be defined further but basically a good exam will demonstrate the following:

- An answer to the main question (e.g. how to approve new medicine X) that is persuasive and pragmatic in terms of its implementation in the real world.
- A thorough research of the issue at hand from all aspects (e.g. CMC, nonclinical, clinical, regulatory strategy) and its pros and cons, including studying and discarding alternative regulatory scenarios to the one finally proposed in the answer.
- Capacity of independent thinking besides simply quoting regulations, that is ability to use the regulations creatively to accelerate or simplify development of new drugs, demonstrating adequate safety and efficacy, to bring them early to patients with minimal burden to the company
- Succinct and persuasive business and regulatory writing considered to be adequate for Pharma/Biotech upper management to accept the strategy and fund it accordingly in terms of full time employees necessary for regulatory and other functions, as well as the regulatory costs of fees
With what percentage do I pass the exam?
 

You must have 50% correct in your essay.

What happens if I fail the exam?
 

The referent will send you a full feedback with comments and ask you to resubmit the essay. This will only happen once so make sure in this second attempt you put the necessary effort.

Certificate

Does the certificate cost extra?

No, the certificate is free of charge.
Will I receive a certificate at the end of the course?

Yes, you will receive a certificate from the College of Medicine and Dentistry after successfully passing the exam. You will also receive 10 ECTS points.
What can I do with the certificate and the ECTS points?
 

In order to develop personally and professionally, it is important to keep your knowledge up to date. With this certificate, you can increase your professional opportunities and prove your further education in the field of regulatory affairs in the form of a certificate.

English test

What happens if I don’t meet the English Language (IELTS) level that are published as entry to the course?
 

Don’t worry COMD can offer you a free diagnostic test with one of our trained English Language assessors. This diagnostic test will give you, and us, an indication of your level of English in the four main components that IELTS tests for:

Writing
Reading
Listening
Speaking
Are there any additional costs for the English test?

No, there are no costs for you. The test is conducted completely free of charge by the College of Medicine and Dentistry.
How do I take the diagnostic test?

We will arrange for you to take this test with one of our trained providers. The test is conducted online, is confidential and lasts approximately 1 hour.
What is involved?


Step one

Once you tell us you want to take this test you will be introduced to one of our trained assessors. You will be asked to write a short essay of no more than 500 words after reading an article on a related topic which will be provided to you by your dedicated assessors. This will help to ascertain your reading and your writing level. Your will email your written piece in to your assessor who will then review this and give feedback.


Step Two

You will then be invited to online meeting with your dedicated assessors and be asked to answer a series of questions. This will assess your listening and spoken levels.

What happens after I take the test?

The assessor will prepare a short report after they have met with you that also incorporates a review of your written essay. This will give an indication of your English language level and highlight any areas where you have strengths and areas that may need a little more work on. You will receive this report and COMD will also review the report. If the report suggests you have a level that might not support you when attending the course COMD staff will consult with your intention to attend. We may suggest you consider taking the course at a later time once you’ve had chance to review the report and work on any areas highlighted.
Why do I need to take the test?

We want you to get the most out of our courses. To do this we have set a minimum English Language requirement for each of the courses.
What happens if my score is low?

If your test indicates a score that we feel is too low and that it might prevent you from getting the most of the course we will discuss this with you. Our primary objective is to ensure that you not only enjoy the course but can achieve your study goals and objectives for attending and by doing so are able to understand the tutors and benefit from the course content fully.
How many times can I take the test?
 

We haven’t set a limit on this and can discuss this with you if this arises.

Contact | Infomaterial

For further information about course content, company terms or our in-house seminars please get in touch with us via email or phone. We look forward to hearing from you.

Elina DeutrichElina Deutrich
Springer Campus Marketing
Tel.:  +49 (0) 6221 487 8428
E-mail: elina.deutrich@springernature.com




Registration | Further information about the course


Course: 

Online (live webinars) and self-directed learning


Co-operation partner: 

College of Medicine and Dentistry, Birmingham (UK) 


Duration | Workload: 

12 weeks

310 hours: 30 contact hours (live webinars), 12 hours e-learning and 268 of directed self-learning.


Level:

Level 6 degree in Pharma, Biomed, Medicine or equivalent

English test: The College of Medicine and Dentistry will do an English test (free of charge) internally to the students. The English test will be one hour maximum and will assess the applicant competencies in Speaking, Reading, Writing and Listening. The test will be focused on pharma issues. This will tick the English Language requirements for the course.


Price:

€ 2200,- (VAT-free)


Certificate

Certificate of the College of Medicine and Dentistry (Birmingham) with 10 ECTS


Upcoming dates:

Start: 15.03.2021 |  Sep 2021 

You can still join the course up to 4 weeks after the start date, but you will have to catch up on the material the referent studied up to that point. Simply register for the course via this page.


Booking:

For Companies:
Companies can book this course for their employees at Springer Campus:

Go to registration 


For private persons:

This course can also be booked directly by private persons: 

Go to registration


Customer recruits customer

You have been or are currently a participant in a Springer Campus Certificate course and know someone in your circle of friends or colleagues who might also be interested in a course? Then you are welcome to recommend us to others! For every successful placement of a participant, you will receive a customer-recruits-customer bonus of EUR 50,-.


AGB