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Management Forum

Clinical Trial Regulatory Requirements Training Course

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation one year on and a brief review of key FDA requirements.

★★★★★ "Content: Fantastic content and material that would help organisations to prepare for the transition ... more"

23-24 Jan 2023
+ 2 more dates

Need help?  Enrol or reserve

  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

Course overview

Are you up to date with the regulatory requirements for clinical research in the EU and key requirements in the US?

Do you understand the impact of the new requirements of the EU Clinical Trials Regulation?

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical trial Regulation and CTIS (Clinical Trial Information system) one year after going live. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.

This interactive programme will highlight the most important of these key requirements and changes and how these are likely to impact on trials now and in the future for pharmaceutical and biotechnology companies and study sites.

Key topics to be covered include:

  • The EU Clinical trials Regulation (536/2014) and update
  • The New Clinical rial Information System (C IS)
  • Clinical trial authorisation
  • Complexities for running paediatric trials
  • Requirements for managing investigational medicinal products
  • Legal aspects of clinical trials
  • Requirements for pharmacovigilance
  • ICH GCP R3 update
  • Regulatory inspections

 

Benefits of attending

  • Decipher the framework of clinical trial regulations and guidelines in Europe
  • Gain an update on the new EU Clinical Trial Regulation 536/2014
  • Review key FDA requirements
  • Understand clinical trial authorisations
  • Assess the most important legal aspects of clinical trials
  • Ensure you comply with pharmacovigilance and adverse event reporting

Who should attend?

This course is ideal for anyone requiring either an overview or refresher of the current clinical trial regulatory and guideline requirements including the new EU Clinical rials Regulation. It will be particularly relevant for those working in regulatory, clinical research, clinical operations, project management and quality assurance (GCP auditors); vendor/CRO professionals; study sites; and other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products.

It will also be of interest to those departments who liaise/support clinical trial personnel (such
as clinical trial supply, pharmacovigilance, quality assurance, document management, legal), regulatory authorities, and any other professionals who want to know more about regulations and guidelines covering clinical trials.

 

Enrol or reserve

The Clinical Trial Regulatory Requirements course will cover:

Overview of the Framework of Clinical Trial Regulations in Europe

  • Background to the history of clinical trial legislation
  • Pharmaceutical clinical trial legislation – EudraLex 10
  • ICH and its importance
  • Key FDA requirements that differ from EU requirements

The New EU Clinical Trials Regulation One Year After Go Live

  • Update one year after the Go Live implementation of the new Clinical Trials Regulation and implementation texts
  • Clinical Trial Transparency
  • The key changes of the Clinical Trials Regulation
  • The new Clinical Trials Information System (CTIS) experience

Clinical Trials Regulatory Authorisation

  • EU clinical trial application (CTA) for submission in the EU
  • Notices and requests for information requirements
  • Substantial changes/modification and non-substantial changes
  • Ongoing and end of study reports including the lay person summary
  • US regulatory requirements for clinical trials – US IND

Ethics Committee (EC) Approval at National Level

  • EC applications as part of the Clinical Trials National Approval
  • Informed consent requirements
  • Ethical considerations for running trials including countries outside of traditional countries

Running Clinical Trials in Children: the Paediatric Plan and Ethical Considerations

  • The EU regulation on paediatric medicines and the paediatric committees
  • Ethical considerations for clinical trials in children guideline

Brief Overview of Legal Aspects of Clinical Trials

  • Data protection – GDPR
  • Enforcement and sanctions
  • Liability and insurance
  • Contracts

Investigational Medicinal Product under the Clinical Trials Regulation

  • GMP requirements and the role of the Qualified Person
  • Labelling requirements
  • Discuss: what inspectors expect for compliance

Pharmacovigilance and Adverse Event Reporting

  • Safety reporting definitions and requirements
  • What are the reporting requirements for SUSARs, adverse events and adverse reactions?
  • RSI (reference safety information)

Awareness of Other Recent EU, FDA and International Developments in Clinical Trial Requirements including:

  • ICH GCP R3
  • EMA Inspections: Questions and Answers on Good Clinical Practice (GCP)
  • Reflection Paper on the Use of Interactive Response Technologies with Particular Emphasis on the Handling of Expiry Dates
  • Accelerating Clinical Trials in the EU
  • Covid regulatory Guidance
  • Clinical trial transparency requirements in the EU 
  • Guidance on real world data
  • EU medical device regulations
  • Requirements for trial master files including electronic TMFs
  • FDA and EU risk-based monitoring guidance
  • FDA guidance on electronic informed consent
  • FDA to increase racial and ethnic diversity in Clinical Trials
  • ICH update

Regulatory Inspection

  • How to prepare for inspection
  • What questions do inspectors ask? Tips on how to answer these.

Enrol or reserve

Laura Brown
LB Training and Development Ltd

Dr Laura Brown is an independent QA and training consultant and director of the MSc in Clinical Research at Cardiff University’s School of Pharmacy. Laura has many years’ experience in the pharmaceutical industry, working for companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a clinical research manager, audit director and as head of a training department and is an international expert on regulatory requirements in clinical research. She was Chair of the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research regulatory requirements. She ha written several articles on the requirements of the EU Clinical Trial Regulation, the impact of Brexit on clinical trials and the ICH GCP R2 guideline.

More details

Book Clinical Trial Regulatory Requirements Live online/Classroom training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

23-24 Jan 2023

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 12140

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 19 Dec

View basket 

 
Not ready to book yet?

for 7 days, no obligation

25-26 May 2023

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 12654

  • GBP 1,299 1,499
  • EUR 1,869 2,149
  • USD 2,137 2,449

Until 20 Apr

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

View basket 

 
Not ready to book yet?

for 7 days, no obligation

18-19 Sep 2023

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12274

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 14 Aug

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's Clinical Trial Regulatory Requirements training course


Content: Fantastic content and material that would help organisations to prepare for the transition into the CTR Presentation: Well presented information especially with the inclusion of audio and video Speaker: Very knowledgeable and open to discussions with the attendees

Jul 14 2022

Ibrahim Busari
Senior Regulatory Affairs Officer, Bio Products Laboratory

Jul 14 2022

Content: Fantastic content and material that would help organisations to prepare for the transition into the CTR Presentation: Well presented information especially with the inclusion of audio and video Speaker: Very knowledgeable and open to discussions with the attendees

Ibrahim Busari
Senior Regulatory Affairs Officer, Bio Products Laboratory

Jan 27 2022

Very on target; Management Forum does an excellent job.

Chiara Delia
Global Regulatory Affairs Specialist, Chiesi Farmaceutici S.p.a.

Jan 27 2022

Laura was very helpful and went out of her way to make sure we understood everything. This course was regarding EU and FDA only but when asked about UK she made sure she got up some extra information regarding this and was very helpful.

Bethany Roome
Clinical Operations Manager, Torbay Pharmaceuticals

Jul 5 2021

Very well organized in terms of content, very well presented, replies for every single question is addressed by the wonderful speaker and I truly enjoyed it and learned so much. Thank you it was excellent!

Nurit Birenboim
Regulatory Affairs Associate, Ayala Pharmaceutical

Jul 5 2021

Very interactive and stimulating.

Margherita Lerro
Study Manager, Menarini Ricerche

Jan 28 2021

Laura was engaged the whole time and really made the presented topics interesting. She also clearly has a wealth of knowledge within the area, so could answer any questions. I liked that even though the course was online it was possible to have breakout into groups with participants talking and discussing together.

Anna Olevik
Regulatory Affairs Manager, Camurus AB

Jan 30 2020

Laura was passionate, knowledgeable and entertaining

Josy Giordano
Regulatory Affairs Manager, Nestec SA

Jan 30 2020

Laura was passionate, knowledgable and entertaining. I particularly liked the group work sessions, which gave us time to digest and use the information just obtained.

Josy Giordano
Regulatory Affairs Manager, Nestec SA

Jan 24 2019

The course is very useful for people new to the field and also the more experienced. The speaker, Laura, was very knowledgeable and open to even the most basic questions on the topic presented.

Ini Okereke
Regulatory Affairs Manager, GW Pharmaceuticals

Jan 24 2019

Useful and recommended for those who are advanced in that topic.

Magdalena Golos
Senior Biopharmaceutics and Clinical Team Manager, Zaklady Farmaceutyczne Polpharma S.A.

Jan 24 2019

Laura was very knowledgable and made the course interactive. We had several group discussions which made the topics clear. The course was excellent and met the criteria I was looking for.

Paul Kelsall
Director of Clinical Manufacturing, Upperton Pharma Solutions

Jul 9 2018

The content of the course is quite comprehensive and the information provided is highly helpful and useful.

Mariia Sorokina
Clinical Covigilance Specialist, Aspen Pharma Trading Limited

Jan 25 2018

Content was correct as an overview, duration was 'not too long' and the speaker (Laura Brown) was concise, direct and straight to the point. Very good!

Russell Pursell
Manufacturing Manager, Quay Pharma

Jan 25 2018

Very helpful and useful for my job.

Anna Zaragoza
Technician, Grifols S.A.

Jan 25 2018

Fantastic, clear, enthusiastic and delivered with a little humour which made it feel interesting and relaxed as opposed to too professional and boring! Would definitely recommend!

Vikesh Lad
Pharmaceutical Assessor, MHRA

Jan 25 2018

Very interesting course, good speaker who was very knowledgable.

Chantal Mutsaers
Regulatory Affairs Scientist, Phara Plus Life Science Services

Jul 9 2018

[The speaker has] ...a solid background related to EU and US regulation and she shares her opinion in a respectful and thoughtful way.

Leonardo Roque Pereira
Global Patient Safety Senior Scientist, Ipsen Biopharm Ltd.

Jul 10 2017

Many thanks for all the additional material.

Gabi Schidler
Senior Manager, Pharmacovigilance, Horizon Pharma GmbH

United Kingdom

  • Torbay Pharmaceuticals
  • AbbVie Inc.
  • Bio Products Laboratory
  • Biogen
  • Cancer Research UK
  • Chugai Pharma Europe Ltd.
  • Clinigen Group PLC
  • Corin Limited
  • CROPrime Ltd
  • EUSA Pharma
  • GE Healthcare
  • GW Pharmaceuticals
  • IMP Pharmaceutical Services Ltd
  • Ipsen Biopharm Ltd
  • Ipsen Biopharm Ltd.
  • Janssen Cilag Ltd
  • MHRA
  • Mundipharma Research Ltd
  • Mundipharma Research Ltd.
  • Opiant Pharmaceuticals
  • PharmaLex UK Services Ltd
  • Pharmedd Services Ltd
  • Quay Pharma
  • Reckitt Benkiser
  • Replimune
  • SPD Development Company
  • ThromboGenics NV
  • UCL
  • University College London
  • Upperton Pharma Solutions
  • Zogenix International Ltd

Germany

  • Bavarian Nordic
  • Bayer AG
  • Boehringer Ingelheim International GmbH
  • Daiichi Sankyo Europe GmbH
  • Horizon Pharma GmbH
  • Life Molecular Imaging GmbH
  • Myelo Therapeutics GmbH

Switzerland

  • Basilea Pharmaceutica International Ltd
  • Celgene
  • F. Hoffmann-La Roche Ltd.
  • MSD Innovation & Development GmbH
  • Nestec SA
  • Santhera Pharmaceuticals (Switzerland) Ltd

France

  • Anticipsante
  • Institut de Recherches Internationales Servier
  • Institut de Recherches Internationales Servier (I.R.I.S.)
  • Janssen Cilag

Italy

  • Chiesi Farmaceutici S.p.a.
  • Menarini Ricerche
  • NMS Group S.P.A
  • Seqirus

Denmark

  • H. Lundbeck A/S
  • Novo Nordisk
  • Novo Nordisk A/S

Ireland

  • Alexion Pharma International Operations UC
  • Aspen Pharma Trading Limited
  • Horizon Pharma Ireland Ltd

Spain

  • Ferrer Internacional
  • Grifols S.A
  • Grifols S.A.

Belgium

  • Phara Plus Life Science Services
  • PhaRa PLUS Life Science Services (BVBA)

Netherlands

  • Interdos Pharma BV
  • Sun Pharmaceutical Industries

Sweden

  • BioGaia AB
  • Camurus AB

United States of America

  • MEI Pharma
  • Regeneron Pharmaceuticals, Inc.

Austria

  • Hookipa Biotech AG

Finland

  • Faron Pharmaceutical Ltd.

Israel

  • Ayala Pharmaceutical

Korea, Republic Of

  • Asan Medical Center

Poland

  • Zaklady Farmaceutyczne Polpharma S.A.

Saudi Arabia

  • Saudi Food and Drug Authority

Enrol or reserve

Run Clinical Trial Regulatory Requirements Live online/Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy