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Life Sciences

The pandemic created numerous challenges across all areas of business worldwide and life science companies responded very quickly. Now, as the healthcare sector emerges stronger and with renewed leadership, the industry can continue to focus on key areas for development and explore ways to challenge existing processes, harness collaborations and build resilience. Our product portfolio has been designed to focus on latest developments and best practice, covering key topics across the pharmaceutical lifecycle, including clinical, regulatory, pharmacovigilance, medical technology, medical writing and biopharma.

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

15-16 Sep 2022 - London

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 Practical Guide to Producing and Maintaining the PSMF Training Course

A Practical Guide to Producing and Maintaining the PSMF

12 Jul 2022 - Online webinar
Also on: 4 Oct 2022

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Presented by Graeme Ladds (bio)

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A Practical Guide to Writing Risk Management Plans (RMPs) Training Course

A Practical Guide to Writing Risk Management Plans (RMPs)

11 Jul 2022 - Online webinar
Also on: 3 Oct 2022

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

Presented by Graeme Ladds (bio)

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Advanced Pharmacovigilance Training Course

Advanced Pharmacovigilance

21-23 Sep 2022 - Online webinar
Also on: 7 Dec 2022

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

Presented by Graeme Ladds (bio)

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Advanced Regulatory Affairs for Medical Devices Training Course

Advanced Regulatory Affairs for Medical Devices

27-28 Sep 2022 - Online webinar

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

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

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Advanced Veterinary Pharmacovigilance Training Course

Advanced Veterinary Pharmacovigilance

21-22 Nov 2022 - Online webinar

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

Presented by Declan O'Rourke (bio)

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An Essential Overview of Pharmacovigilance Training Course

An Essential Overview of Pharmacovigilance

10 Oct 2022 - Online webinar

A practical guide to understanding the role of pharmacovigilance.

Presented by Graeme Ladds (bio)

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An Essential Overview of the Medical Device Industry Training Course

An Essential Overview of the Medical Device Industry

2 Nov 2022 - Online webinar

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

16 Sep 2022 - Online webinar

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 Pharmaceutical Packaging Training Course

An Introduction to Pharmaceutical Packaging

13-14 Jun 2022 - Online webinar
Also on: 28 Sep 2022

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

Presented by Chris Penfold (bio)

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An Introduction to Quality Management for Managers Training Course

An Introduction to Quality Management for Managers

15 Jun 2022 - Online webinar
Also on: 15 Sep 2022

This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.

Presented by Rob Hughes (bio)

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An Introduction to the Design and Development of Medical Devices Training Course

An Introduction to the Design and Development of Medical Devices

4-5 Jul 2022 - Online webinar
Also on: 4 Oct 2022

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Presented by David Howlett (bio)

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An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

1-3 Aug 2022 - London
Also on: 8 Nov 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)

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

Best Practice for Writing Effective SOPs

27 Jun 2022 - Online webinar
Also on: 19 Sep 2022

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

Presented by Laura Brown (bio)

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Biosimilars Training Course

Biosimilars

4-5 Jul 2022 - Online webinar
Also on: 11 Oct 2022

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

Presented by Marloes van der Geer (bio)

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Biotechnology for the Non-Biotechnologist Training Course

Biotechnology for the Non-Biotechnologist

27 Jun-1 Jul 2022 - Online webinar
Also on: 28 Sep 2022

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

Presented by Robert Alvarez (bio)
and 6 more leading experts

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Borderlines between Medicines and Food Training Course

Borderlines between Medicines and Food

16 Jun 2022 - Online webinar
Also on: 1 Dec 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)

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CAPA (Corrective and Preventative Action) Training Course

CAPA (Corrective and Preventative Action)

28 Jun 2022 - Online webinar
Also on: 20 Sep 2022

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 Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

8-9 Aug 2022 - London
Also on: 28 Nov 2022

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Presented by Janette Benaddi (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

5-6 Oct 2022 - 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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Clinical Quality Management Systems Training Course

Clinical Quality Management Systems

17-18 Nov 2022 - Online webinar

A two-day course that will ensure you comply with new regulatory requirements.

Presented by Laura Brown (bio)

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Clinical Trial Monitoring Training Course

Clinical Trial Monitoring

18-19 Jul 2022 - Online webinar
Also on: 3 Oct 2022

This course will assure monitors understand the importance of compliance with GCP standards, and how these apply to monitoring clinical trials including during the pandemic and in the future.

Presented by Laura Brown (bio)

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Clinical Trial Regulatory Requirements Training Course

Clinical Trial Regulatory Requirements

14-15 Jul 2022 - Online webinar

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 key difference it compares with the Clinical Directive requirements.

Presented by Laura Brown (bio)

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Common Technical Document Training Course

Common Technical Document

18-19 Jul 2022 - Online webinar
Also on: 28 Nov 2022

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Presented by Hans van Bruggen (bio)
Marloes van der Geer (bio)

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Cyber Security for Medical Devices Training Course

Cyber Security for Medical Devices

19 Jul 2022 - Online webinar
Also on: 11 Oct 2022

The impact of Cyber Security incidents on society is high, and in critical infrastructures such as healthcare it impacts the ability for hospitals to provide care. Cybersecurity for medical devices is not just about safety, it should also protect the confidentiality, integrity and availability of systems and data. This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

Presented by Ben Kokx (bio)

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Data Integrity and Document Management Training Course

Data Integrity and Document Management

7 Jul 2022 - Online webinar
Also on: 10 Oct 2022

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

Presented by Laura Brown (bio)

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Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

7-8 Nov 2022 - Online webinar

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Presented by David Howlett (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

29-30 Sep 2022 - Online webinar
Also on: 14 Dec 2022

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (bio)
and 3 more leading experts

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Effective Technical Writing & Editing Training Course

Effective Technical Writing & Editing

15 Jun 2022 - Online webinar
Also on: 30 Sep 2022

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Presented by Barbara Grossman (bio)

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Effective Technology Transfer Training Course

Effective Technology Transfer

4-5 Jul 2022 - Online webinar
Also on: 11 Oct 2022

The ‘how to’ of technology transfer across the product lifecycle

Presented by Bruce Davis (bio)

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EU (European Union) Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers Training Course

EU Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers

8 Nov 2022 - Online webinar
Also on: 1 Mar 2023

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

Presented by Koen Cobbaert (bio)

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EU (European Union) Clinical Trial Regulation 536/2014: Overview and Implementation Training Course

EU Clinical Trial Regulation 536/2014: Overview and Implementation

23-24 May 2022 - Online webinar
Also on: 4 Jul 2022

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU

Presented by Laura Brown (bio)

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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

5-6 Jul 2022 - Online webinar
Also on: 18 Oct 2022

This interactive course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation.

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

22-23 Jun 2022 - Online webinar
Also on: 12 Sep 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)

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Filing eCTD Submissions Training Course

Filing eCTD Submissions

11 Jul 2022 - Online webinar
Also on: 19 Oct 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)

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GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course

GCP and Clinical Research Update - Hot Inspection Topics

23 Sep 2022 - Online webinar

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

Presented by Laura Brown (bio)

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GMP (Good Manufacturing Practice) Fundamentals Training Course

GMP Fundamentals

30 Jun-1 Jul 2022 - Online webinar
Also on: 18 Oct 2022

This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.

Presented by Rob Hughes (bio)

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Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course

Human Factors and Usability Engineering in the Development of Drug Delivery Products

14-15 Sep 2022 - Online webinar
Also on: 7 Dec 2022

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Presented by Richard Featherstone (bio)

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

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

3-4 Nov 2022 - Online webinar

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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Introduction to Veterinary Pharmacovigilance Training Course

Introduction to Veterinary Pharmacovigilance

18-19 Oct 2022 - Online webinar

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

*INCLUDES: Interactive workshop and discussion sessions*

Presented by Declan O'Rourke (bio)

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Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course

Managing Vendor/CRO/CMO Oversight

11-12 Jul 2022 - London
Also on: 17 Oct 2022

Optimising oversight for inspection compliance

Presented by Laura Brown (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

5-6 Jul 2022 - Online webinar
Also on: 12 Oct 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)

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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

15-16 Jun 2022 - Online webinar
Also on: 20 Sep 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)

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Medical Device Single Audit Programme (MDSAP) Training Course

Medical Device Single Audit Programme (MDSAP)

7-8 Jul 2022 - Online webinar
Also on: 1 Dec 2022

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices.
This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

Presented by Eamonn Hoxey (bio)

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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

4-7 Jul 2022 - London
Also on: 4 Oct 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)

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Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

15-16 Aug 2022 - Online webinar
Also on: 14 Nov 2022

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Presented by Janette Benaddi (bio)

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Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

19-20 Sep 2022 - Online webinar

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Presented by Janette Benaddi (bio)

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Medical Writing for Medical Devices Training Course

Medical Writing for Medical Devices

5-6 Jul 2022 - Online webinar
Also on: 19 Oct 2022

How to produce quality regulatory documents including the clinical evaluation report (CER)

Presented by Janette Benaddi (bio)
Barbara Grossman (bio)

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Metered Dose Inhaler (MDI) Technology Training Course

Metered Dose Inhaler (MDI) Technology

13-14 Sep 2022 - Online webinar

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Presented by David Howlett (bio)

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New Regulations for Medical Devices and IVDs in Europe Training Course

New Regulations for Medical Devices and IVDs in Europe

30 Jun-1 Jul 2022 - Online webinar
Also on: 13 Oct 2022

During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.

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

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Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

14-15 Jul 2022 - Online webinar
Also on: 6 Oct 2022

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Presented by Andrew Willis (bio)

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Pharmaceutical Packaging, Labelling and Artwork Origination Training Course

Pharmaceutical Packaging, Labelling and Artwork Origination

12-13 Dec 2022 - Online webinar

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

Presented by George Barrie (bio)
and 6 more leading experts

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Pharmaceutical Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

25-26 May 2022 - Online webinar
Also on: 23 Nov 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)

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Pharmaceutical Regulatory Affairs in Asia Training Course

Pharmaceutical Regulatory Affairs in Asia

12-14 Oct 2022 - 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

24-25 May 2022 - Online webinar
Also on: 22 Nov 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)

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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

15-16 Aug 2022 - 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

29-30 Jun 2022 - Online webinar
Also on: 14 Dec 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)

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Pharmacovigilance Training Course

Pharmacovigilance

21-23 Jun 2022 - Online webinar
Also on: 20 Sep 2022

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

Presented by Glyn Belcher (bio)
and 5 more leading experts

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Pharmacovigilance Aspects of Licensing Agreements Training Course

Pharmacovigilance Aspects of Licensing Agreements

13 Jul 2022 - Online webinar
Also on: 17 Oct 2022

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

Presented by Joanne Flitcroft (bio)
Graeme Ladds (bio)

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Pharmacovigilance QMS & Inspection Preparation Training Course

Pharmacovigilance QMS & Inspection Preparation

23-24 May 2022 - Online webinar
Also on: 16 Nov 2022

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

Presented by Graeme Ladds (bio)

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Practical Implementation of GCP (Good Clinical Practice) in Veterinary Field Studies Training Course

Practical Implementation of GCP in Veterinary Field Studies

29-30 Nov 2022 - Online webinar

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

Presented by Tamsin Dawson (bio)
Donna Taylor (bio)
Jenny Webster (bio)

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Pre-Filled Syringes: End-to-End Processing Training Course

Pre-Filled Syringes: End-to-End Processing

21 Sep 2022 - Online webinar

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

Presented by Dale Charlton (bio)
Andreas Rothmund (bio)

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Process Validation with Qualification Training Course

Process Validation with Qualification

20-21 Jun 2022 - London
Also on: 26 Sep 2022

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Presented by Bruce Davis (bio)

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Quality Management Refresher Training Course

Quality Management Refresher

29 Sep 2022 - London
Also on: 26 Jan 2023

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management.
It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

Presented by Rob Hughes (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

14-15 Sep 2022 - 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 Nick Wills (bio)

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Regulatory Affairs for Support Staff Training Course

Regulatory Affairs for Support Staff

27-28 Jun 2022 - London
Also on: 27 Sep 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)

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Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

20 Jun 2022 - Online webinar
Also on: 26 Sep 2022

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

Presented by Marloes van der Geer (bio)

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Risk Management for Pharma and Biopharma Professionals Training Course

Risk Management for Pharma and Biopharma Professionals

14 Oct 2022 - Online webinar

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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Signal Detection and Regulatory Expectations Training Course

Signal Detection and Regulatory Expectations

29-30 Nov 2022 - Online webinar

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

Presented by Graeme Ladds (bio)

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Smart Packaging and Electronic Patient Information Training Course

Smart Packaging and Electronic Patient Information

13 Jul 2022 - London
Also on: 2 Nov 2022

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

Presented by Christopher Waterhouse (bio)

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Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course

Stability Testing of Pharmaceuticals and Biopharmaceuticals

14-15 Jul 2022 - Online webinar

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Presented by Paul Palmer (bio)

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Sterilization of Medical Devices Training Course

Sterilization of Medical Devices

20-21 Oct 2022 - Online webinar
Also on: 2 Feb 2023

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

Presented by Eamonn Hoxey (bio)

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Successful Medical Writing Training Course

Successful Medical Writing

11-13 Jul 2022 - Online webinar
Also on: 11 Oct 2022

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

Presented by Barry Drees (bio)
Barbara Grossman (bio)
James Visanji (bio)

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Sustainable Design and Manufacture for Medical Devices Training Course

Sustainable Design and Manufacture for Medical Devices

6 Jul 2022 - Online webinar
Also on: 6 Oct 2022

Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.

Presented by Cormac O'Prey (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

22-23 Nov 2022 - Online webinar

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

27-28 Jun 2022 - Online webinar
Also on: 19 Sep 2022

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

Presented by Hans van Bruggen (bio)
Marloes van der Geer (bio)

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

The Medical Device School - From Concept to CE Marking

13-17 Jun 2022 - Online webinar
Also on: 5 Dec 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 Nick Baker (bio)
and 7 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

3-4 Nov 2022 - Online webinar

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.

Presented by Karolina Bate (bio)
Mel Munro (bio)

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UK Conformity Assessed (UKCA) Marking for Medical Devices Training Course

UK Conformity Assessed (UKCA) Marking for Medical Devices

13 Jul 2022 - Online webinar
Also on: 3 Nov 2022

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.
The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements.
This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.

Presented by Janette Benaddi (bio)

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Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

7-8 Jul 2022 - Online webinar
Also on: 13 Oct 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.

Presented by Marloes van der Geer (bio)

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

Veterinary Pharmaceutical Submissions in the EU

9-10 Jun 2022 - Online webinar
Also on: 13 Dec 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 Andrew Hewitt (bio)
Dave Parry (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

20-24 Jun 2022 - Online webinar

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

Presented by Andrew Hewitt (bio)
David Petrick (bio)

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