- Next: 15-16 Sep 2022 Classroom
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
Classroom
Focused
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.
- 12 CPD hours
-
Presented by Dr Mel Munro
-
and Dr Tamsin Dawson
- Next: 12 Jul 2022 Live online
- Also: 4 Oct 2022 Classroom
A Practical Guide to Producing and Maintaining the PSMF
Live online, Classroom
Focused
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.
- 6 CPD hours
-
Presented by Dr Graeme Ladds
- Next: 11 Jul 2022 Live online
- Also: 3 Oct 2022 Classroom
A Practical Guide to Writing Risk Management Plans (RMPs)
Live online, Classroom
Focused
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
- 6 CPD hours
-
Presented by Dr Graeme Ladds
- Next: 21-23 Sep 2022 Live online
- Also: 7-9 Dec 2022 Classroom
Advanced Pharmacovigilance
Live online, Classroom
Focused
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.
- 18 CPD hours
-
Presented by Dr Graeme Ladds
- Next: 27-28 Sep 2022 Live online
Advanced Regulatory Affairs for Medical Devices
Live online
Focused
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
- 12 CPD hours
-
Presented by Ms Janette Benaddi
-
and Ms Theresa Jeary
- Next: 21-22 Nov 2022 Live online
Advanced Veterinary Pharmacovigilance
Live online
Focused
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
- 12 CPD hours
-
Presented by Mr Declan O'Rourke
- Next: 10 Oct 2022 Live online
An Essential Overview of Pharmacovigilance
Live online
Focused
A practical guide to understanding the role of pharmacovigilance.
- 6 CPD hours
-
Presented by Dr Graeme Ladds
- Next: 2 Nov 2022 Live online
An Essential Overview of the Medical Device Industry
Live online
Focused
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.
- 6 CPD hours
-
Presented by Dr David Jefferys
-
and Ms Theresa Jeary
- Next: 16 Sep 2022 Live online
An Essential Overview of the Pharmaceutical and Biotech Industries
Live online
Focused
This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.
- 6 CPD hours
-
Presented by Dr Laura Brown
- Next: 13-14 Jun 2022 Live online
- Also: 28-29 Sep 2022 Live online
An Introduction to Pharmaceutical Packaging
Live online
Focused
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.
- 12 CPD hours
-
Presented by Mr Chris Penfold
- Next: 15 Jun 2022 Live online
- Also: 15 Sep 2022 Live online
- Also: 13 Dec 2022 Classroom
An Introduction to Quality Management for Managers
Live online, Classroom
Focused
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.
- 6 CPD hours
-
Presented by Rob Hughes
- Next: 4-5 Jul 2022 Live online
- Also: 4-5 Oct 2022 Live online
An Introduction to the Design and Development of Medical Devices
Live online
Focused
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
- 12 CPD hours
-
Presented by Mr David Howlett
- Next: 18-20 May 2022 Live online
- Also: 1-3 Aug 2022 Classroom
- Also: 8-10 Nov 2022 Live online
An Introduction to the Medical Device Regulation
Live online, Classroom
Focused
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.
- 18 CPD hours
-
Presented by Ms Janette Benaddi
-
+ 2 more
- Next: 27 Jun 2022 Live online
- Also: 19 Sep 2022 Classroom
- Also: 12 Dec 2022 Live online
Best Practice for Writing Effective SOPs
Live online, Classroom
Focused
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
- 6 CPD hours
-
Presented by Dr Laura Brown
- Next: 1-2 Aug 2022 Classroom
Biological Evaluation of Medical Devices
Classroom
Focused
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
- 12 CPD hours
-
Presented by Mr Philip Clay
- Next: 4-5 Jul 2022 Live online
- Also: 11-12 Oct 2022 Live online
Biosimilars
Live online
Focused
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
- 12 CPD hours
-
Presented by Marloes van der Geer
- Next: 27 Jun-1 Jul 2022 Live online
- Also: 28-30 Sep 2022 Classroom
Biotechnology for the Non-Biotechnologist
Live online, Classroom
Focused
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
- 18 CPD hours
-
Presented by Dr Adekunle Onadipe
-
+ 8 more
- Next: 16 Jun 2022 Live online
- Also: 1 Dec 2022 Live online
Borderlines between Medicines and Food
Live online
Focused
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
- 6 CPD hours
-
Presented by David Richardson
-
+ 2 more
- Next: 28 Jun 2022 Live online
- Also: 20 Sep 2022 Classroom
- Also: 13 Dec 2022 Live online
CAPA (Corrective and Preventative Action)
Live online, Classroom
Focused
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.
- 6 CPD hours
-
Presented by Dr Laura Brown
- Next: 8-9 Aug 2022 Classroom
- Also: 28-29 Nov 2022 Live online
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
Live online, Classroom
Focused
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
- 12 CPD hours
-
Presented by Ms Janette Benaddi
- Next: 5-6 Oct 2022 Live online
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
Live online
Focused
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)
- 6 CPD hours
-
Presented by Dr John Price
- Next: 17-18 Nov 2022 Live online
Clinical Quality Management Systems
Live online
Focused
A two-day course that will ensure you comply with new regulatory requirements.
- 12 CPD hours
-
Presented by Dr Laura Brown
- Next: 18-19 Jul 2022 Live online
- Also: 3-4 Oct 2022 Live online
Clinical Trial Monitoring
Live online
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.
- 12 CPD hours
-
Presented by Dr Laura Brown
- Next: 14-15 Jul 2022 Live online
Clinical Trial Regulatory Requirements
Live online
Focused
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.
- 12 CPD hours
-
Presented by Dr Laura Brown
- Next: 28-29 Nov 2022 Live online
Common Technical Document
Live online
Focused
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
- 12 CPD hours
-
Presented by Hans van Bruggen
-
and Marloes van der Geer
- Next: 19 Jul 2022 Live online
- Also: 11 Oct 2022 Live online
- Also: 20 Jan 2023 Classroom
Cyber Security for Medical Devices
Live online, Classroom
Focused
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.
- 6 CPD hours
-
Presented by Mr Ben Kokx
- Next: 7 Jul 2022 Live online
- Also: 10 Oct 2022 Live online
Data Integrity and Document Management
Live online
Focused
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.
- 6 CPD hours
-
Presented by Dr Laura Brown
- Next: 7-8 Nov 2022 Live online
Development of Combination Products: Critical Interactions
Live online
Focused
Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.
- 12 CPD hours
-
Presented by Mr David Howlett
- Next: 29-30 Sep 2022 Live online
- Also: 14-15 Dec 2022 Classroom
Drug/Device and Device/Drug Combinations in the EU and USA
Live online, Classroom
Focused
Practical guidance on borderline Issues and combination products
- 12 CPD hours
-
Presented by Dr David Jefferys
-
+ 3 more
- Next: 15 Jun 2022 Live online
- Also: 30 Sep 2022 Live online
- Also: 14 Dec 2022 Classroom
Effective Technical Writing & Editing
Live online, Classroom
Focused
Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.
- 6 CPD hours
-
Presented by Ms Barbara Grossman
- Next: 4-5 Jul 2022 Classroom
- Also: 11-12 Oct 2022 Live online
Effective Technology Transfer
Live online, Classroom
Focused
The ‘how to’ of technology transfer across the product lifecycle
- 12 CPD hours
-
Presented by Mr Bruce Davis
- Next: 8 Nov 2022 Live online
- Also: 1 Mar 2023 Live online
- Also: 13 Jul 2023 Live online
- Also: 9 Nov 2023 Live online
EU Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers
Live online
Focused
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.
- 3 CPD hours
-
Presented by Mr Koen Cobbaert
- Next: 23-24 May 2022 Live online
- Also: 4-5 Jul 2022 Classroom
- Also: 20-21 Oct 2022 Live online
EU Clinical Trial Regulation 536/2014: Overview and Implementation
Live online, Classroom
Focused
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
- 12 CPD hours
-
Presented by Dr Laura Brown
- Next: 5-6 Jul 2022 Live online
- Also: 18-19 Oct 2022 Live online
EU Pharmaceutical Regulations & Strategy
Live online
Focused
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.
- 12 CPD hours
-
Presented by Mrs Norah Lightowler
- Next: 22-23 Jun 2022 Live online
- Also: 12-13 Sep 2022 Live online
- Also: 5-6 Dec 2022 Classroom
FDA Approval Process for Medical Devices
Live online, Classroom
Focused
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.
- 12 CPD hours
-
Presented by Dr Jonathan Hughes
- Next: 11 Jul 2022 Live online
- Also: 19 Oct 2022 Live online
Filing eCTD Submissions
Live online
Focused
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
- 6 CPD hours
-
Presented by Maikel Bouman
-
and Marloes van der Geer
- Next: 23 Sep 2022 Live online
GCP and Clinical Research Update - Hot Inspection Topics
Live online
Focused
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
- 6 CPD hours
-
Presented by Dr Laura Brown
- Next: 30 Jun-1 Jul 2022 Live online
- Also: 18-19 Oct 2022 Live online
- Also: 18-19 Jan 2023 Classroom
GMP Fundamentals
Live online, Classroom
Focused
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
- Next: 14-15 Sep 2022 Live online
- Also: 7-8 Dec 2022 Classroom
Human Factors and Usability Engineering in the Development of Drug Delivery Products
Live online, Classroom
Focused
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.
- 12 CPD hours
-
Presented by Mr Richard Featherstone
- Next: 3-4 Nov 2022 Live online
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
Live online
Focused
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.
- 12 CPD hours
-
Presented by Nancy Consterdine
-
and Stuart Angell
- Next: 5-6 Jul 2022 Classroom
- Also: 18-19 Oct 2022 Live online
Introduction to Veterinary Pharmacovigilance
Live online, Classroom
Focused
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*
- 12 CPD hours
-
Presented by Mr Declan O'Rourke
- Next: 11-12 Jul 2022 Classroom
- Also: 17-18 Oct 2022 Live online
Managing Vendor/CRO/CMO Oversight
Live online, Classroom
Focused
Optimising oversight for inspection compliance
- 12 CPD hours
-
Presented by Dr Laura Brown
- Next: 5-6 Jul 2022 Live online
- Also: 12-13 Oct 2022 Live online
Medical Device Regulation in the Eurasion Union, Russia and the CIS
Live online
Focused
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.
- 12 CPD hours
-
Presented by Mrs Anna Harrington-Morozova
- Next: 15-16 Jun 2022 Live online
- Also: 20-21 Sep 2022 Classroom
- Also: 7-8 Dec 2022 Live online
Medical Device Regulations in the Middle East and North Africa
Live online, Classroom
Focused
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
- 12 CPD hours
-
Presented by Ms Heba Hashem
-
and Ms Ilona Putz
- Next: 7-8 Jul 2022 Live online
- Also: 1-2 Dec 2022 Classroom
- Also: 23-24 Mar 2023 Live online
Medical Device Single Audit Programme (MDSAP)
Live online, Classroom
Focused
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.
- 12 CPD hours
-
Presented by Dr Eamonn Hoxey
- Next: 4-7 Jul 2022 Classroom
- Also: 4-7 Oct 2022 Live online
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
Live online, Classroom
Focused
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
- 24 CPD hours
-
Presented by Mr Koen Cobbaert
-
and Mrs Zuzanna Kwade
- Next: 15-16 Aug 2022 Classroom
- Also: 14-15 Nov 2022 Live online
Medical Device Studies: Clinical Evidence
Live online, Classroom
Focused
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
- 12 CPD hours
-
Presented by Ms Janette Benaddi
- Next: 19-20 Sep 2022 Live online
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
Live online
Focused
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
- 12 CPD hours
-
Presented by Ms Janette Benaddi
- Next: 5-6 Jul 2022 Live online
- Also: 19-20 Oct 2022 Live online
Medical Writing for Medical Devices
Live online
Focused
How to produce quality regulatory documents including the clinical evaluation report (CER)
- 12 CPD hours
-
Presented by Ms Barbara Grossman
-
and Ms Janette Benaddi
- Next: 13-14 Sep 2022 Live online
Metered Dose Inhaler (MDI) Technology
Live online
Focused
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
- 12 CPD hours
-
Presented by Mr David Howlett
- Next: 30 Jun-1 Jul 2022 Live online
- Also: 13-14 Oct 2022 Live online
New Regulations for Medical Devices and IVDs in Europe
Live online
Focused
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.
- 12 CPD hours
-
Presented by Dr David Jefferys
-
+ 2 more
- Next: 14-15 Jul 2022 Live online
- Also: 6-7 Oct 2022 Live online
Pharmaceutical Development of ATMPs
Live online
Focused
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
- 12 CPD hours
-
Presented by Mr Andrew Willis
- Next: 12-13 Dec 2022 Live online
Pharmaceutical Packaging, Labelling and Artwork Origination
Live online
Focused
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.
- 12 CPD hours
-
Presented by Mr Christopher Waterhouse
-
+ 6 more
- Next: 25-26 May 2022 Live online
- Also: 23-24 Nov 2022 Live online
Pharmaceutical Regulatory Affairs in Africa
Live online
Focused
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
- 12 CPD hours
-
Presented by Mr Makram Nehme
-
and Salma Ismail
- Next: 12-14 Oct 2022 Live online
Pharmaceutical Regulatory Affairs in Asia
Live online
Focused
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
- 18 CPD hours
-
Presented by Dr Alan Chalmers
-
and Ms Monica Dressler-Meyer
- Next: 24-25 May 2022 Live online
- Also: 22-23 Nov 2022 Live online
Pharmaceutical Regulatory Affairs in China
Live online
Focused
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
- 12 CPD hours
-
Presented by Dr Alan Chalmers
-
and Ms Monica Dressler-Meyer
- Next: 15-16 Aug 2022 Live online
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
Live online
Focused
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
- 12 CPD hours
-
Presented by Mrs Anna Harrington-Morozova
- Next: 29-30 Jun 2022 Live online
- Also: 14-15 Dec 2022 Live online
Pharmaceutical Regulatory Affairs in the Middle East
Live online
Focused
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
- 12 CPD hours
-
Presented by Ms Heba Hashem
-
and Ms Ilona Putz
- Next: 21-23 Jun 2022 Live online
- Also: 20-22 Sep 2022 Classroom
- Also: 14-16 Dec 2022 Live online
Pharmacovigilance
Live online, Classroom
Focused
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.
- 18 CPD hours
-
Presented by Dr Glyn Belcher
-
+ 5 more
- Next: 13 Jul 2022 Live online
- Also: 17 Oct 2022 Live online
Pharmacovigilance Aspects of Licensing Agreements
Live online
Focused
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
- 6 CPD hours
-
Presented by Joanne Flitcroft
-
and Dr Graeme Ladds
- Next: 23-24 May 2022 Live online
- Also: 16-17 Nov 2022 Live online
Pharmacovigilance QMS & Inspection Preparation
Live online
Focused
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
- 12 CPD hours
-
Presented by Dr Graeme Ladds
- Next: 29-30 Nov 2022 Live online
Practical Implementation of GCP in Veterinary Field Studies
Live online
Focused
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.
- 12 CPD hours
-
Presented by Donna Taylor
-
+ 2 more
- Next: 21 Sep 2022 Live online
Pre-Filled Syringes: End-to-End Processing
Live online
Focused
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.
- 6 CPD hours
-
Presented by Andreas Rothmund
-
and Dr. Dale Charlton
- Next: 20-21 Jun 2022 Classroom
- Also: 26-27 Sep 2022 Live online
Process Validation with Qualification
Live online, Classroom
Focused
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.
- 12 CPD hours
-
Presented by Mr Bruce Davis
- Next: 29 Sep 2022 Classroom
- Also: 26 Jan 2023 Live online
Quality Management Refresher
Live online, Classroom
Focused
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.
- 6 CPD hours
-
Presented by Rob Hughes
- Next: on request
Registration of Animal Feed Additives in the EU
Bespoke
Focused
This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
- 12 CPD hours
- Next: 14-15 Sep 2022 Live online
Registration of Veterinary Vaccines in the USA and Canada
Live online
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.
- 6 CPD hours
-
Presented by Nick Wills
- Next: 27-28 Jun 2022 Classroom
- Also: 27-28 Sep 2022 Live online
Regulatory Affairs for Support Staff
Live online, Classroom
Focused
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.
- 12 CPD hours
-
Presented by Mrs Norah Lightowler
- Next: 20 Jun 2022 Live online
- Also: 26 Sep 2022 Live online
Regulatory Strategies for Orphan Drugs
Live online
Focused
This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
- 6 CPD hours
-
Presented by Marloes van der Geer
- Next: 14 Oct 2022 Live online
Risk Management for Pharma and Biopharma Professionals
Live online
Focused
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.
- 6 CPD hours
-
Presented by Dr Laura Brown
- Next: 29-30 Nov 2022 Live online
Signal Detection and Regulatory Expectations
Live online
Focused
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
- 12 CPD hours
-
Presented by Dr Graeme Ladds
- Next: 13 Jul 2022 Classroom
- Also: 2 Nov 2022 Classroom
Smart Packaging and Electronic Patient Information
Classroom
Focused
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.
- 6 CPD hours
-
Presented by Mr Christopher Waterhouse
- Next: 14-15 Jul 2022 Live online
Stability Testing of Pharmaceuticals and Biopharmaceuticals
Live online
Focused
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.
- 12 CPD hours
-
Presented by Paul Palmer
- Next: 20-21 Oct 2022 Live online
- Also: 2-3 Feb 2023 Classroom
- Also: 1-2 Jun 2023 Live online
Sterilization of Medical Devices
Live online, Classroom
Focused
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.
- 12 CPD hours
-
Presented by Dr Eamonn Hoxey
- Next: 11-13 Jul 2022 Live online
- Also: 11-13 Oct 2022 Live online
Successful Medical Writing
Live online
Focused
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.
- 18 CPD hours
-
Presented by Ms Barbara Grossman
-
+ 2 more
- 19 Jan 2022
Sustainable Design and Manufacture for Medical Devices
Recorded webcast
High impact
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 free webinar will give you a high level of understanding of what sustainability options exist, what the benefits are and what drives them.
-
Presented by Cormac O'Prey
- Next: 6 Jul 2022 Live online
- Also: 6 Oct 2022 Live online
- Also: 24 Jan 2023 Classroom
Sustainable Design and Manufacture for Medical Devices
Live online, Classroom
Focused
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.
- 6 CPD hours
-
Presented by Cormac O'Prey
- Next: 22-23 Nov 2022 Live online
Technical Documentation to Comply with the MDR and IVDR
Live online
Focused
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.
- 12 CPD hours
-
Presented by Paul Sim
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and Mr Will Burton
- Next: 27-28 Jun 2022 Live online
- Also: 19-20 Sep 2022 Live online
The FDA Drug Approval Process
Live online
Focused
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
- 12 CPD hours
-
Presented by Hans van Bruggen
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and Marloes van der Geer
- Next: 13-17 Jun 2022 Live online
- Also: 5-9 Dec 2022 Live online
The Medical Device School - From Concept to CE Marking
Live online
Intensive
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.
- 30 CPD hours
-
Presented by Mr David Howlett
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+ 7 more
- Next: 3-4 Nov 2022 Live online
The New EU Animal Health Legislation for Veterinary Medicinal Products
Live online
Focused
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.
- 12 CPD hours
-
Presented by Karolina Bate
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and Dr Mel Munro
- Next: 13 Jul 2022 Live online
- Also: 3 Nov 2022 Live online
- Also: 3 Mar 2023 Live online
UK Conformity Assessed (UKCA) Marking for Medical Devices
Live online
Focused
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.
- 6 CPD hours
-
Presented by Ms Janette Benaddi
- Self-paced
Understanding the Pharmaceutical Industry
Self-paced
A 6 MODULE SELF-MANAGED DISTANCE LEARNING COURSE – An insider’s guide to the pharmaceutical industry for anyone new who wants to enhance their knowledge on working in the pharma, bio-tech or life sciences sectors. Gain key skills needed with this 6 module course requiring 3 to 4 hours study each module.
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Mr John Ansell
- Next: 7-8 Jul 2022 Live online
- Also: 13-14 Oct 2022 Live online
Variations to Marketing Authorisations
Live online
Focused
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.
- 12 CPD hours
-
Presented by Marloes van der Geer
- Next: 9-10 Jun 2022 Live online
- Also: 13-14 Dec 2022 Live online
Veterinary Pharmaceutical Submissions in the EU
Live online
Focused
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.
- 12 CPD hours
-
Presented by Andrew Hewitt
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and Dave Parry
- Next: 20-24 Jun 2022 Live online
Working Through Veterinary Drug Development in the EU and USA
Live online
Intensive
This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
- 24 CPD hours
-
Presented by Andrew Hewitt
-
and David Petrick