Online training during Covid restrictions - our programes continue this spring in online webinar format

Training courses & Webinars:
Regulatory

 

A Regulatory Update on Animal Feed and Feed Additives in the EU (European Union), USA and China Training Course

A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China

2-3 Dec 2021 - Online webinar
Also on: 9 Dec 2021

Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.

Presented by Elinor McCartney (bio)

View details

Advanced Regulatory Affairs for Medical Devices Training Course

Advanced Regulatory Affairs for Medical Devices

20-21 Apr 2021 - Online webinar
Also on: 28 Sep 2021

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)

View details

An Essential Overview of the Medical Device Industry Training Course

An Essential Overview of the Medical Device Industry

13 May 2021 - Online webinar
Also on: 18 Oct 2021

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

Presented by Theresa Jeary (bio)
David Jefferys (bio)

View details

An Essential Overview of the Pharmaceutical and Biotech Industries Training Course

An Essential Overview of the Pharmaceutical and Biotech Industries

7 May 2021 - Online webinar
Also on: 16 Sep 2021

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

Presented by Laura Brown (bio)

View details

An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

12-14 May 2021 - Online webinar
Also on: 10 Nov 2021

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Presented by Janette Benaddi (bio)
Will Burton (bio)
Theresa Jeary (bio)

View details

Biological Evaluation of Medical Devices Training Course

Biological Evaluation of Medical Devices

23-24 Nov 2021 - London

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.

*Includes:* Interactive workshops and discussion sessions

Presented by Philip Clay (bio)
Janine Ingleby (bio)

View details

Borderlines between Medicines and Food Training Course

Borderlines between Medicines and Food

9 Dec 2021 - London
Also on: 10 Dec 2021

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

Presented by Penny Viner (bio)

View details

CAPA (Corrective and Preventative Action) Training Course

CAPA (Corrective and Preventative Action)

29 Jun 2021 - Online webinar
Also on: 3 Dec 2021

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

Presented by Laura Brown (bio)

View details

Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Drug/Device and Device/Drug Combinations in the EU and USA

28-29 Apr 2021 - Online webinar
Also on: 29 Sep 2021

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (bio)
and 4 more leading experts

View details

EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

18-19 Oct 2021 - London
Also on: 21 Oct 2021

This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations.

The impact of the end of the Brexit transition period will be discussed.

Presented by Norah Lightowler (bio)

View details

FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

13-14 Sep 2021 - London
Also on: 15 Sep 2021

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Presented by Jonathan Hughes (bio)

View details

Filing eCTD Submissions Training Course

Filing eCTD Submissions

13 Apr 2021 - Online webinar
Also on: 18 Oct 2021

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

Presented by Maikel Bouman (bio)
Marloes van der Geer (bio)

View details

How to Write Effective SOPs (Standard Operating Procedures) Training Course

How to Write Effective SOPs

28 Jun 2021 - Online webinar
Also on: 2 Dec 2021

An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.

Presented by Laura Brown (bio)

View details

Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

11-12 May 2021 - Online webinar
Also on: 2 Nov 2021

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Presented by Stuart Angell (bio)
Nancy Consterdine (bio)

View details

Medical Device Regulation in the Eurasian Union, Russia and the CIS Training Course

Medical Device Regulation in the Eurasian Union, Russia and the CIS

6-7 Oct 2021 - Online webinar
Also on: 13 Oct 2021

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

Presented by Anna Harrington-Morozova (bio)

View details

Medical Device Regulations in the Middle East and North Africa Training Course

Medical Device Regulations in the Middle East and North Africa

30 Jun-1 Jul 2021 - Online webinar

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

*Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen*

Presented by Heba Hashem (bio)
Ilona Putz (bio)

View details

Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the EU MDR & FDA Regulations

28-30 Apr 2021 - Online webinar
Also on: 27 Oct 2021

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Presented by Koen Cobbaert (bio)
Zuzanna Kwade (bio)

View details

New Medical Device Regulation Training Course

New Medical Device Regulation

12-13 Oct 2021 - Online webinar
Also on: 14 Oct 2021

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)
David Jefferys (bio)

View details

Periodic Safety Update Reports for Veterinary Medicinal Products Training Course

Periodic Safety Update Reports for Veterinary Medicinal Products

11-12 May 2021 - Online webinar
Also on: 19 Oct 2021

Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit

*NEW EVENT!*

Presented by Declan O'Rourke (bio)

View details

Pharmaceutical Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

26-27 May 2021 - Online webinar

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

Presented by Salma Ismail (bio)
Makram Nehme (bio)

View details

Pharmaceutical Regulatory Affairs in China Training Course

Pharmaceutical Regulatory Affairs in China

17-18 Nov 2021 - London
Also on: 24 Nov 2021

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

View details

Pharmaceutical Regulatory Affairs in the Middle East Training Course

Pharmaceutical Regulatory Affairs in the Middle East

28-29 Jun 2021 - Online webinar

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

Presented by Heba Hashem (bio)
Ilona Putz (bio)

View details

Registration of Animal Feed Additives in the EU (European Union) Training Course

Registration of Animal Feed Additives in the EU

16-17 Jun 2021 - Online webinar

This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

Presented by Joan Castelló (bio)
Elinor McCartney (bio)

View details

Regulatory Affairs for Support Staff Training Course

Regulatory Affairs for Support Staff

27-28 Sep 2021 - Online webinar
Also on: 29 Sep 2021

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

Presented by Norah Lightowler (bio)

View details

Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

22 Sep 2021 - Online webinar
Also on: 29 Sep 2021

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Presented by Andrew Willis (bio)

View details

Risk Management for Pharma and Biopharma Professionals Training Course

Risk Management for Pharma and Biopharma Professionals

21 Sep 2021 - London
Also on: 23 Sep 2021

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.

Presented by Laura Brown (bio)

View details

Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course

Technical Documentation to Comply with the MDR and IVDR

22-23 Nov 2021 - London
Also on: 24 Nov 2021

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

Presented by Will Burton (bio)
Paul Sim (bio)

View details

The FDA (Food and Drug Administration) Drug Approval Process Training Course

The FDA Drug Approval Process

20-21 Sep 2021 - Online webinar
Also on: 27 Sep 2021

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Presented by Andrew Willis (bio)

View details

The Medical Device Summer School - From Concept to CE Marking Training Course

The Medical Device Summer School - From Concept to CE Marking

5-9 Jul 2021 - London

*A practical five-day course with interactive workshops - now in its 17th successful year!*

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

Presented by Nick Baker (bio)
and 6 more leading experts

View details

The New EU (European Union) Animal Health Legislation for Veterinary Medicinal Products Training Course

The New EU Animal Health Legislation for Veterinary Medicinal Products

5-6 May 2021 - Online webinar
Also on: 2 Nov 2021

The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

*INCLUDES: Interactive discussion sessions*

Presented by Julian Braidwood (bio)

View details

Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

13-14 Apr 2021 - Online webinar
Also on: 7 Oct 2021

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Presented by Andrew Willis (bio)

View details

Veterinary Pharmaceutical Submissions in the EU (European Union) Training Course

Veterinary Pharmaceutical Submissions in the EU

6-7 Dec 2021 - Online webinar
Also on: 8 Dec 2021

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.

Presented by Julian Braidwood (bio)

View details

Working Through Veterinary Drug Development in the EU (European Union) and USA Training Course

Working Through Veterinary Drug Development in the EU and USA

21-25 Jun 2021 - Online webinar

This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.

Presented by Julian Braidwood (bio)
David Petrick (bio)

View details

I liked the webinar very much, because it provided a comprehensive and detailed overview of the ODD process in the EU and other countries. Andrew presented himself as an excellent speaker who answered all questions of the participants in a very detailed and knowledgeable manner.

Burkhard Siefert, ,

It was a very interesting and useful webinar. I would definitely recommend it.

Fernando Bergantinos, Manager. Drug Safety Scientist, Daiichi Sankyo Europe GmbH

It was a very nice webinar and met my expectations. The slides were well structured and the content nicely presented. It was great to profit from John´s huge experience.

Katharina Broeker, Scientific Expert, Department of Medical Affairs, Medac GmbH

Very dynamic and interesting speaker, interactive webinar.

Anna Sarao, Regulatory Affairs Project Manager, Servier

Very dynamic and interesting speaker, interactive webinar.

Anna Sarao, Regulatory Affairs Project Manager, Servier

Great speaker, tremendous experience. I am extremely satisfied with the level of information and knowledge acquired throughout the last 2 days. I would definitely recommend this course and this format to all stakeholders approaching the Veterinary Pharmaceutical Submissions in the EU.

Alessio Giannelli, Regulatory Science Liaison, Inovet

I was overall happy with the webinar. Julian was very clear and ready to answer any question throughout the webinar.

Veronica Nannetti, , Fatro Spa

Very good overall.

Ilaria Grisoni, Senior Director, Head of EU/International PV Office & EEA QPPV, Gentium S.r.l. (Jazz Pharmaceuticals Company)

The Webinar contains useful information and it is very interesting but there is a lot of information for only two-day course.

Silvia Santano Hernandez, Regulatory Affairs Technician, Grifols S.A.

Really helpful and reassuring to know that I have understood the situation thus far. Also helped to identify areas where I can look for more information.

Shirley-Ann van der Spuy, Managing Director & EU QPPV, Red Line Pharmacovigilance Ltd