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. 

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. 

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.

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:

€ 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:

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