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.
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.
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
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 and emergency use new medicine
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 construction
- Provide an overview and individual granularity discussion of the 5 modules of the CTD
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
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
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
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
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
Week 5: Nonclinical Safety Regulatory Science
Aims of this Week:
- Describe the 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
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
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 |
| 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.
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.
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 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:
€ 2.200,- (VAT-free)
Certificate
Certificate of the College of Medicine and Dentistry (Birmingham) with 10 ECTS
Upcoming dates:
Start: 17.03.2021 (Registration deadline: 10.03.2021) | Sep 2021
If you would still like to join after the application deadline, simply contact us and we will check whether you can still join the course.
Booking:
For Companies:
Companies can book this course for their employees at Springer Campus:
For private persons:
This course can also be booked directly by private persons:
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,-.