Post Graduate Award in Regulatory Affairs

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 & self study - Start in April 2024

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 the self study part?
VLE (Virtual Learning Environment) Content Self Study: It's not interactive. The referant tape and/or post slides for the participants to consult in their own time. Normally, the slides are provided at the beginning of each week on Mondays or Tuesdays.
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.

As of January 2024, subject to change.

Your referent

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.

Cooperation partner: College of Medicine & Dentistry, Birmingham (UK)

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.

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