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

Training courses & Webinars:
Regulatory

 

A Practical Approach to Veterinary Vaccine Development and Registration in the EU (European Union) Training Course

A Practical Approach to Veterinary Vaccine Development and Registration in the EU

9-10 Mar 2021 - Online webinar

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

Presented by Tamsin Dawson (bio)
Mel Munro (bio)

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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)

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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)

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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)

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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)

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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)

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Biological Evaluation of Medical Devices Training Course

Biological Evaluation of Medical Devices

18-19 May 2021 - London
Also on: 23 Nov 2021

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)

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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)

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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)

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Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

30 Mar 2021 - Online webinar

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

Presented by John Price (bio)

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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

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (bio)
Elizabeth Baker (bio)
David Jefferys (bio)

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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

19-20 Apr 2021 - Online webinar
Also on: 18 Oct 2021

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

Presented by Norah Lightowler (bio)

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

FDA Approval Process for Medical Devices

24-25 Mar 2021 - Online webinar
Also on: 13 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)

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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 Justin Bailey (bio)
Jasbir Chohan (bio)

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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)

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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)

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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)

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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)

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

Medical Device Software: Complying with the 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)

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New Medical Device Regulation Training Course

New Medical Device Regulation

17-18 Mar 2021 - Online webinar
Also on: 12 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)

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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)

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Pharmaceutical Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

22-23 Mar 2021 - Online webinar

Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia and Zimbabwe.

Presented by Salma Ismail (bio)

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Pharmaceutical Regulatory Affairs in Asia Training Course

Pharmaceutical Regulatory Affairs in Asia

7-9 Apr 2021 - Online webinar

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

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

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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)

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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

4-5 Feb 2021 - Online webinar

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

Presented by Anna Harrington-Morozova (bio)

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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)

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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)

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Registration of Veterinary Vaccines in the USA and Canada Training Course

Registration of Veterinary Vaccines in the USA and Canada

11 Mar 2021 - Online webinar

This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.

Presented by Donna Mattson (bio)

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Regulatory Affairs for Support Staff Training Course

Regulatory Affairs for Support Staff

18-19 Mar 2021 - Online webinar
Also on: 27 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)

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Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

10 Mar 2021 - Online webinar
Also on: 22 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)

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Risk Management for Pharma and Biopharma Professionals Training Course

Risk Management for Pharma and Biopharma Professionals

22 Mar 2021 - Online webinar
Also on: 21 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)

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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

10-11 Mar 2021 - Online webinar
Also on: 22 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)

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

The FDA Drug Approval Process

11-12 Mar 2021 - Online webinar
Also on: 20 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)

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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 8 more leading experts

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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)

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Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

25-26 Mar 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)

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

Veterinary Pharmaceutical Submissions in the EU

3-4 Mar 2021 - Online webinar
Also on: 6 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)

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

Working Through Veterinary Drug Development in the EU and USA

7-10 Jun 2021 - London

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

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

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The speakers were very professional, detailed in providing information and they promoted interactions/questions in order to try to deepen together the topics covered.

Teresa Bruno, Regulatory Affairs Officer, MENARINI RICERCHE SPA

I think it has been very useful and interesting, and I believe most people has been involved and participating, which makes it lively and helps you keep in the flow when doing online training.

Luis Mancera Pascual, Executive Director, Clover Bioanalytical Software, Ltd

The seminar was very good, the speakers and slides were very professionals and it covers wide aspects of the learned subjects.

Avital Levertov, Regulatory Affairs Manager, Elcam Medical Ltd

Very good, especially the opportunity to ask specific questions to the speaker with so much experience on the field.

Laia Gispert, Regulatory affairs Expert, GALENICUM HEALTH, S.L.

The webinar was really ideal for persons/companies willing to register their product in the EEA. The speaker was also excellent, involving the attendants with her particular questions, which provided a broader content.

Gokce Erdem, Regulatory Affairs Manager, Turgut Pharmaceuticals

The speakers were very helpful and supportive in answering any questions.

Rand Qeshta, Regulatory Affairs Manager , Recordati Ireland

I enjoyed the webinar very much, both presenters were very good and showed their depth of knowledge.

Sabrina Solomon, Safety Scientist, Ipsen

Content = good however some of the points were of little relevance to me.
Presentation = excellent. Very clear slides and the speed of delivery was perfect.
Speaker = excellent. Very knowledgeable and happy to discuss topics in depth if required

Rodney Cartmill, Head of Regulatory Affairs - New Products, Norbrook Laboratories Ltd

Very good knowledge of the topics from the speaker.

Inês Almeida, Regulatory Affairs Manager, BIAL - Portela & C.ª, S.A.

Very friendly speaker.

Edouard Timsit, chef de projet recherche - ruminant, CEVA SANTE ANIMAL