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

6-7 Sep 2021 - Online webinar
Also on: 17 Mar 2022

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)

View details

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: 1 Jun 2022

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

28-29 Sep 2021 - Online webinar
Also on: 1 Mar 2022

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

18 Oct 2021 - Online webinar
Also on: 23 May 2022

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

17 Sep 2021 - Online webinar
Also on: 1 Mar 2022

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

10-12 Nov 2021 - Online webinar
Also on: 8 Feb 2022

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

Best Practice for Writing Effective SOPs (Standard Operating Procedures) Training Course

Best Practice for Writing Effective SOPs

20 Sep 2021 - London
Also on: 2 Dec 2021

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

Presented by Laura Brown (bio)

View details

Biological Evaluation of Medical Devices Training Course

Biological Evaluation of Medical Devices

23-24 Nov 2021 - London
Also on: 8 Feb 2022

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

10 Dec 2021 - Online webinar
Also on: 16 Jun 2022

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 Brian Kelly (bio)
David Richardson (bio)
Penny Viner (bio)

View details

CAPA (Corrective and Preventative Action) Training Course

CAPA (Corrective and Preventative Action)

21 Sep 2021 - London
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

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

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

10 Sep 2021 - Online webinar
Also on: 30 Mar 2022

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)

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

29-30 Sep 2021 - Online webinar
Also on: 1 Dec 2021

Practical guidance on borderline Issues and combination products

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

View details

EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

21-22 Oct 2021 - Online webinar
Also on: 11 Apr 2022

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

15-16 Sep 2021 - Online webinar
Also on: 29 Mar 2022

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

20 Oct 2021 - Online webinar
Also on: 18 Jan 2022

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

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

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

2-3 Nov 2021 - Online webinar
Also on: 19 May 2022

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: 12 Apr 2022

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

8-9 Dec 2021 - Online webinar
Also on: 15 Jun 2022

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), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations Training Course

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

26-29 Oct 2021 - Online webinar
Also on: 25 Apr 2022

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

11-12 Oct 2021 - Online webinar
Also on: 12 Apr 2022

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

Pharmaceutical Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

29-30 Nov 2021 - Online webinar
Also on: 25 May 2022

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 Asia Training Course

Pharmaceutical Regulatory Affairs in Asia

13-15 Oct 2021 - Online webinar
Also on: 20 Apr 2022

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)

View details

Pharmaceutical Regulatory Affairs in China Training Course

Pharmaceutical Regulatory Affairs in China

24-25 Nov 2021 - Online webinar
Also on: 25 May 2022

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 Russia and the Eurasian Union Training Course

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

3-4 Feb 2022 - Online webinar
Also on: 15 Aug 2022

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)

View details

Pharmaceutical Regulatory Affairs in the Middle East Training Course

Pharmaceutical Regulatory Affairs in the Middle East

15-16 Dec 2021 - Online webinar
Also on: 29 Jun 2022

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

14-15 Dec 2021 - Online webinar
Also on: 20 Jun 2022

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 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: 28 Mar 2022

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: 16 Mar 2022

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

Risk Management for Pharma and Biopharma Professionals Training Course

Risk Management for Pharma and Biopharma Professionals

23 Sep 2021 - Online webinar
Also on: 29 Apr 2022

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

24-25 Nov 2021 - Online webinar
Also on: 25 May 2022

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: 21 Mar 2022

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

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

The Medical Device School - From Concept to CE Marking

6-10 Dec 2021 - Online webinar
Also on: 13 Jun 2022

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 Janette Benaddi (bio)

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

2-3 Nov 2021 - Online webinar
Also on: 16 May 2022

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

14-15 Oct 2021 - Online webinar
Also on: 26 Apr 2022

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.

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

Veterinary Pharmaceutical Submissions in the EU

6-7 Dec 2021 - Online webinar
Also on: 9 Jun 2022

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

20-24 Jun 2022 - Online webinar
Also on: 5 Dec 2022

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

Great session, thank you

Kasia Stathers, Vigilance Officer , Reckitt Benckiser Group

I wanted to learn more about regulations in the middle east and the content was definitely very informative. The speakers had a lot of knowledge, there were a few technical issues however these were quickly resolved.

Hafsa Khan, Regulatory Associate, Gilead Sciences International Ltd

The webinar was prepared in a high quality manner.

Michel Salatiel Guzman Gomez, , Boehringer Ingelheim Vetmedica GmbH

Excellent speakers, different styles but all very good.

Dora Rodriguez, Regulatory Affairs Director, Jefo Nutrition Inc.

Overall talks were very good and I learned a lot (as I'm kind of new to this area). I liked that so many questions could be answered from the participants. online tools was also very good.

Eline Klaassens, Product Manager Human Health, Baseclear

This webinar was really helpful for me, although I'm a bit new in this registration process I think that now I will be able to do it. The content and the presentations were complete and detailed and the speakers were experts in this matter and answered all of our questions, they were also really friendly which is always nice. It was a same that we couldn't meet in person.

Monica Longares, , Lucta, S.A.

All the webinar was very interesting and useful, but I liked particularly the workshops sessions with concrete examples.

Tifenn PERROT, Responsable réglementaire, ALL4FEED

Really useful refresher on CAPA and the processes used. It has helped me prioritise and categorise CAPA types, and I found particularly useful the section on risk scoring and utilising the risk register for those classified as minor.

Claire Crewe, QA Maanger, JensonR+

The content was very useful and all speakers were at adequate level. Workshops helped me a lot to digest the content of presentations.

Athanasios Karalis, Product Stewardship Manager, IMERYS INDUSTRIAL MINERALS S.A

Very useful, gave me the needed information, excellent speakers.

Elina Koskinen, , Orion Corporation