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:

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. 

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). 
 

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	October 4, 2021	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	October 4, 2021	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	1 - 2.5	October 6, 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	October 11, 2021	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	October 11, 2021	Flexible time management of the participant
2	Common Technical Document (CTD) format for Regulatory Applications	Overview of the 5 modules of the CTD	Webinar	1 - 2.5	October 13, 2021	18.30
3	Regulatory Intelligence and Strategy	The differences between laws, regulations, guidelines, scientific advice, precedents	Lecture	0.5	October 18, 2021	Flexible time management of the participant
3	Regulatory Intelligence and Strategy	Exploring Regulatory Intelligence and Precedents from FDA and EMA	Lecture	0.5	October 18, 2021	Flexible time management of the participant
3	Regulatory Intelligence and Strategy	Regulatory Strategy and Planning	Webinar	1 - 2.5	October 20, 2021	18.30
4	Chemistry Manufacturing and Controls (CMC)  Regulatory  – Small molecules	What is CMC regulatory	Lecture	0.5	October 25, 2021	Flexible time management of the participant
4	Chemistry Manufacturing and Controls (CMC)  Regulatory  – Small molecules	The Main ICH Quality Guidelines	Lecture	0.5	October 25, 2021	Flexible time management of the participant
4	Chemistry Manufacturing and Controls (CMC)  Regulatory  – Small molecules	CMC regulatory for small molecules and biologicals	Webinar	1 - 2.5	October 27, 2021	18.30
5	Nonclinical Safety  Regulatory Science	The ICH Nonclinical Safety Guidelines (fundamental for small molecules/new chemical entities)	Lecture	0.5	November 1, 2021	Flexible time management of the participant
5	Nonclinical Safety  Regulatory Science	The ICH Nonclinical Safety Guidelines for Novel Biologics	Lecture	0.5	November 1, 2021	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	1 - 2.5	November 3, 2021	18.30
6	Clinical and Regulatory New Drug Development	First-in-Human Regulatory Issues (Nonclinical basis and Phase I clinical trials)	Lecture	0.5	November 8, 2021	Flexible time management of the participant
6	Clinical and Regulatory New Drug Development	Phase 2 and Phase 3 Clinical Regulatory Affairs - Clinical Protocols and Good Clinical Practices	Lecture	0.5	November 8, 2021	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	1 - 2.5	November 10, 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	November 15, 2021	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	November 15, 2021	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	1 - 2.5	November 17, 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	November 22, 2021	Flexible time management of the participant
8	Scientific Advice Meetings with Regulatory Agencies	Scientific advice consultation from EMA or other EU Health Authorities, for adults and pediatric indications	Lecture	0.5	November 22, 2021	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	1 - 2.5	November 24, 2021	18.30
9	Filing and Approval of New Drugs/Medicines	Marketing Authorization Applications (MAA)	Lecture	0.5	November 29, 2021	Flexible time management of the participant
9	Filing and Approval of New Drugs/Medicines	New Drug Applications (NDA)	Lecture	0.5	November 29, 2021	Flexible time management of the participant
9	Filing and Approval of New Drugs/Medicines	Biologics License Application (BLA)	Webinar	1 - 2.5	December 1, 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	December 6, 2021	Flexible time management of the participant
10	Post-approval and marketing regulatory compliance	Variations to an Approved Application	Lecture	0.5	December 6, 2021	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	1 - 2.5	December 8, 2021	18.30
11	International  Regulatory Filings	Japan PMDA and China NMPA registrations	Lecture	0.5	December 14, 2021	Flexible time management of the participant
11	International  Regulatory Filings	Rest of the World Registration.  Brazil ANVISA and Australia TGA Examples.	Lecture	0.5	December 14, 2021	Flexible time management of the participant
11	International  Regulatory Filings	Questions and Answers	Webinar	1 - 2.5	December 16, 2021	18.30
12	Life Cycle Management  of New Drug Indications	New Indications	Lecture	0.5	December 20, 2021	Flexible time management of the participant
12	Life Cycle Management	New formulations (New Dosage Forms)	Lecture	0.5	December 20, 2021	Flexible time management of the participant
12	Life Cycle Management	Questions and Answers.  Introduction to the written assignment, Distribution of the Assignment	Webinar	1 - 2.5	December 22, 2021	18.30
Written assignment	Take Home Exam	Due January 31, 2022

As of June 2021, subject to change.

Peter Caetano

Peter 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.

Established 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.

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 assignment within six weeks 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.

Who is this course for? The course is suitable for anyone who wants to acquire a solid knowledge of regulatory affairs as practiced in the pharmaceuticals and biotech industry. Previous professional experience in this field is not necessary but a strong scientific background in disciplines relevant to the pharmaceutical industry is strongly recommended.  Such backgrounds  include the fields of pharmacology, pharmaceutics, medicine, pharmacy, medical technology, biotechnology, molecular biology, toxicology, food chemistry, or similar fields. Both basics and advanced level knowledge will be taught. People already working in the professional field of regulatory affairs can also benefit from the speaker's large experience and broad knowledge, as well as from the challenging and practical assignments simulating regulatory decision making and advice all the way to company board level.  Beginners in this field, as long as they have solid and relevant scientific background and are willing to invest the time in exploring fully the guidances and source documents quoted in the slides,  can follow the course well and take away plenty of regulatory information and ability.  The schedule is perfect if you’re working in a company or university department involved in drug development, parallel with taking the course. This so that you can apply and discuss there what you have learned while the regulatory topics for new drug development are being discussed in class. Of course, you can also participate if you do not work part-time. Career changers are also welcome as regulatory affairs is a profession frequently taken by experienced or qualified scientists coming from diverse areas.

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 does "Level 6 degree" in Pharma, Biomed, Medicine or equivalent mean?   The "Level 6 degree" is equivalent to a Bachelor's degree. If you have completed an apprenticeship or similar instead, please feel free to contact us. We will check whether we can admit you to the course.

What is the minimum number of participants for the course? The minimum number of participants for the course is 5.

What is the maximum number of participants for the course? In order to guarantee high quality content, excellent learning performance and optimal discussion rounds, the course is limited to a maximum of 25 participants.

What is the level of the course? The level of the course is beginner - advanced. The lectures have the necessary breadth and depth of pharmaceuticals/biotech regulatory affairs to suit students with a diverse range of previous regulatory affairs experience. Those who are beginners will have an opportunity to explore the many source documents and references quoted in the lectures, besides asking questions in class, in order to catch up for the graded regulatory assignments.

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. Only then, when you have successfully passed everything, you will 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 VLE (Virtual Learning Environment) 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 VLE, 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.

Assignments

Are there intermediate assignments between the individual webinars?   Besides the final assignment 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 assignment at the end of the course?   Yes you have to hand in a final assignment which will consist of a take home written examination.

How can I imagine the final assignment?   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 assignment, 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 assignment 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 assignment? How it will look like?   You will receive it in the final week of the course and will have six weeks 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 assignment then? Do I upload it to VLE (Virtual Learning Environment) or do I send it directly to the lecturer by email?   Ideally the written assignment should be uploaded on VLE. Emailing of assignments is a possibility only if VLE 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 VLE 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 assignment? Six weeks. The final assignment is a take home exam requiring research. Students have six weeks 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 assignment.

Is it possible to give more than six weeks for the final assignment in Regulatory Affairs?   Unfortunately, not, the final assignment has to be written in six weeks.

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 assignment 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 assignment?   You must have 50% correct in your essay.

What happens if I fail the assignment?   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.

When will I receive feedback on my assignment?   Approx. after 3 weeks. CoMD will distribute the feedback to the students individually.

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 assignment. 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.

When will I get the certificate?   You will receive the certificate directly from COMD after your homework has been checked and you have passed it.

Does the certificate include an overall grade or grades for the individual modules?   No, on the certificate will be no grades mentioned. Like all awarding organisations, COMD only issue a certificate when achievement has been made. The certificate is accompanied by a transcript indicating the units that have also been achieved. We do not list any marks that have been achieved on a unit by unit basis. COMD will state the course name and completed.