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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 and existing Directive requirements.

27-28 Jan 2022

& 14-15 Jul 2022

Book now

Details

Course overview

Are you up to date with the regulatory requirements for clinical research?

Do you understand the impact and new requirements of the EU Clinical Trial 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 existing Directive requirements. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.

The 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 current requirements of the EU Clinical Trials Directive
  • The EU Clinical Trial Regulation (536/2014)
  • The impact of Brexit
  • Clinical trial authorisations
  • Complexities for running paediatric trials
  • Requirements for managing investigational medicinal products
  • Legal aspects of clinical trials
  • Requirements of pharmacovigilance
  • ICH 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: regulatory and ethical approval
  • 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 and an update on the new EU Clinical Trial 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.

Programme

Understand the current framework of clinical trial regulations in Europe

  • Pharmaceutical clinical trial legislation – EudraLex 10 contents explained
  • ICH and its importance
  • Key FDA requirements which differ from EU requirements
  • The impact of Brexit

Overview of the current EU clinical trials requirements

  • The key requirements of the EU Clinical Trials Directive
  • Case study – main issues of the Clinical Trials Directive and why this will be replaced with the Clinical Trial Regulation

The new EU Clinical Trial Regulation

  • Update on the new Clinical Trial Regulation, timescale for applications, implementing acts, EU portal and database and new documentation
  • What key changes will be introduced?
  • Implementation and compliance

Clinical trial regulatory authorisation and amendments

  • How to apply for the EudraCT number
  • Current requirements for an EU clinical trial application (CTA) and how this will change with the new Clinical Trial Regulation
  • Substantial amendments and non-substantial amendments
  • US regulatory requirements for clinical trials – US IND

Ethics Committee (EC) submissions and approval

  • Roles and responsibilities: sponsor and investigators
  • Completing EC applications
  • Informed consent requirement

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
  • Contracts

Investigational medicinal product

  • 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?

Awareness of other recent EU and FDA developments in clinical trial requirements

  • Clinical trial transparency requirements in the EU – recent EMA policy on publication of clinical data
  • Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
  • EU medical device regulations
  • New EU requirements for trial master files including electronic TMFs
  • New FDA and EU risk-based monitoring guidance
  • FDA guidance on electronic informed consent
  • ICH update

Presenter

Laura Brown (More...)

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.

Book now

Book now

27-28 Jan 2022
Live webinar
27-28 Jan 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 23 Dec*
Enrol now
to attend
Live webinar
14-15 Jul 2022
Live webinar
14-15 Jul 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 9 Jun 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Ayala Pharmaceutical
  • Basilea Pharmaceutica International Ltd
  • BioGaia AB
  • Chiesi Farmaceutici S.p.a.
  • CROPrime Ltd
  • Daiichi Sankyo Europe GmbH
  • EUSA Pharma
  • F. Hoffmann-La Roche Ltd.
  • GE Healthcare
  • Grifols S.A.
  • Hookipa Biotech GmbH
  • Horizon Pharma Ireland Ltd
  • Institut de Recherches Internationales Servier
  • Institut de Recherches Internationales Servier (I.R.I.S.)
  • Ipsen Biopharm Ltd
  • Ipsen Biopharm Ltd.
  • Janssen Cilag
  • Menarini Ricerche
  • MSD Innovation & Development GmbH
  • Mundipharma Research Ltd
  • Nestec SA
  • Novo Nordisk A/S
  • Opiant Pharmaceuticals
  • Phara Plus Life Science Services
  • Regeneron Pharmaceuticals, Inc.
  • Santhera Pharmaceuticals (Switzerland) Ltd
  • Seqirus
  • Sun Pharmaceutical Industries
  • Zaklady Farmaceutyczne Polpharma S.A.
  • Zogenix International Ltd

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 21

Very interactive and stimulating.

Margherita Lerro, Study Manager, Menarini Ricerche, Jul 21

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 21

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 20

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, Jan 19

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 19

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 19

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

Leonardo Roque Pereira, Global Patient Safety Senior Scientist, Ipsen Biopharm Ltd., Jul 18

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, Jul 18

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 18

Very helpful and useful for my job.

Anna Zaragoza, Technician, Grifols S.A., Jan 18

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 18

Very interesting course, good speaker who was very knowledgable.

Chantal Mutsaers, Regulatory Affairs Scientist, Phara Plus Life Science Services, Jan 18

Many thanks for all the additional material.

Gabi Schidler, Senior Manager, Pharmacovigilance, Horizon Pharma GmbH, Jul 17