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A Practical Guide to Producing and Maintaining the PSMF
29 Jun 2021 - Online webinar
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)
A Practical Guide to Writing Risk Management Plans (RMPs)
28 Jun 2021 - Online webinar
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
2-3 Dec 2021 - Online webinar
Also on: 9 Dec 2021
Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.
Presented by Elinor McCartney (bio)
Advanced Pharmacovigilance
22-24 Sep 2021 - Online webinar
Also on: 29 Sep 2021
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)
Advanced Regulatory Affairs for Medical Devices
28-29 Sep 2021 - Online webinar
Also on: 30 Sep 2021
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Advanced Veterinary Pharmacovigilance
23-24 Jun 2021 - Online webinar
Also on: 22 Nov 2021
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)
Agile Leadership for Pharma and Biopharma Professionals in a virtual world
28-29 Sep 2021 - London
Also on: 30 Sep 2021
This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results
Presented by Laura Brown (bio)
An Essential Overview of Pharmacovigilance
4 Oct 2021 - Online webinar
Also on: 5 Oct 2021
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
An Essential Overview of the Medical Device Industry
18 Oct 2021 - Online webinar
Also on: 19 Oct 2021
This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.
An Essential Overview of the Pharmaceutical and Biotech Industries
16 Sep 2021 - London
Also on: 17 Sep 2021
This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.
Presented by Laura Brown (bio)
An Introduction to Pharmaceutical Packaging
28-29 Sep 2021 - Online webinar
Also on: 30 Sep 2021
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)
An Introduction to the Design and Development of Medical Devices
11-12 Oct 2021 - London
Also on: 13 Oct 2021
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
Presented by David Howlett (bio)
An Introduction to the Medical Device Regulation
10-12 Nov 2021 - Online webinar
Also on: 17 Nov 2021
This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.
Best Practice for Writing Effective SOPs
28 Jun 2021 - Online webinar
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)
Biological Evaluation of Medical Devices
23-24 Nov 2021 - London
Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.
*Includes:* Interactive workshops and discussion sessions
Biosimilars
5-6 Oct 2021 - Online webinar
Also on: 12 Oct 2021
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
NEW EVENT!
Presented by Andrew Willis (bio)
Biotechnology for the Non-Biotechnologist
29 Sep-1 Oct 2021 - Online webinar
Also on: 6 Oct 2021
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Presented by
Adrian Haines (bio)
and 5 more leading experts
Borderlines between Medicines and Food
9 Dec 2021 - London
Also on: 10 Dec 2021
This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them
Presented by Penny Viner (bio)
CAPA (Corrective and Preventative Action)
29 Jun 2021 - Online webinar
Also on: 3 Dec 2021
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.
Presented by Laura Brown (bio)
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
29-30 Nov 2021 - London
Also on: 1 Dec 2021
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Presented by Janette Benaddi (bio)
Clinical Quality Management Systems
18-19 Nov 2021 - Online webinar
Also on: 25 Nov 2021
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Laura Brown (bio)
Clinical Trial Regulatory Requirements
5-6 Jul 2021 - 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 existing Directive requirements.
Presented by Laura Brown (bio)
Common Technical Document
6-7 Jul 2021 - Online webinar
Also on: 29 Nov 2021
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Presented by Andrew Willis (bio)
Critical Thinking for Pharma and Biopharma Professionals
9 Jul 2021 - Online webinar
Also on: 22 Nov 2021
This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals
Presented by Laura Brown (bio)
Data Integrity and Document Management
4 Oct 2021 - Online webinar
Also on: 5 Oct 2021
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)
Development of Combination Products: Critical Interactions
9-10 Nov 2021 - Online webinar
Also on: 11 Nov 2021
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Presented by Andrew Willis (bio)
Drafting and Negotiating Clinical Trial Agreements
4 Nov 2021 - London
Also on: 5 Nov 2021
This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted
Drafting Commercial Contracts for the Pharmaceutical Industry
24-26 Nov 2021 - Online webinar
A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.
Presented by
James Agnew (bio)
and 15 more leading experts
Drug/Device and Device/Drug Combinations in the EU and USA
29-30 Sep 2021 - Online webinar
Practical guidance on borderline Issues and combination products
Presented by
Tina Amini (bio)
and 3 more leading experts
Effective Technical Writing & Editing
23 Sep 2021 - London
Also on: 24 Sep 2021
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)
Effective Technology Transfer
5-6 Oct 2021 - Online webinar
Also on: 7 Oct 2021
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
EU Clinical Trial Regulation: Overview and Implementation
18-19 Oct 2021 - Online webinar
Also on: 20 Oct 2021
This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU
Presented by Laura Brown (bio)
EU Pharmaceutical Regulations & Strategy
18-19 Oct 2021 - London
Also on: 21 Oct 2021
This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations.
The impact of the end of the Brexit transition period will be discussed.
Presented by Norah Lightowler (bio)
FDA Approval Process for Medical Devices
13-14 Sep 2021 - London
Also on: 15 Sep 2021
This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.
Presented by Jonathan Hughes (bio)
Filing eCTD Submissions
18 Oct 2021 - London
Also on: 19 Oct 2021
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
GCP and Clinical Research Update - Hot Inspection Topics
22 Sep 2021 - London
Also on: 24 Sep 2021
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)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
20-21 Sep 2021 - London
Also on: 22 Sep 2021
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)
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
2-3 Nov 2021 - Online webinar
Also on: 4 Nov 2021
This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.
Introduction to Veterinary Pharmacovigilance
12-13 Oct 2021 - Online webinar
Also on: 14 Oct 2021
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)
Managing Vendor/CRO/CMO Oversight
7-8 Oct 2021 - Online webinar
Also on: 11 Oct 2021
Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource
Presented by Laura Brown (bio)
MBA Strategic Thinking for Pharma and Biopharma
6-7 Sep 2021 - Online webinar
Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure including the impact of COVID-19, is probably one of the most challenging managerial roles of any industry today.
Presented by Laura Brown (bio)
Medical Device Regulation in the Eurasian Union, Russia and the CIS
6-7 Oct 2021 - Online webinar
Also on: 13 Oct 2021
A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
Presented by Anna Harrington-Morozova (bio)
Medical Device Regulations in the Middle East and North Africa
30 Jun-1 Jul 2021 - Online webinar
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.
Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen
Medical Device Software: Complying with the EU MDR & FDA Regulations
26-29 Oct 2021 - Online webinar
Also on: 2 Nov 2021
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Medical Device Studies: Clinical Evidence
8-9 Nov 2021 - Online webinar
Also on: 15 Nov 2021
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
20-21 Sep 2021 - London
Also on: 22 Sep 2021
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)
Medical Writing for Medical Devices
19-20 Oct 2021 - Online webinar
Also on: 21 Oct 2021
How to produce quality regulatory documents including the clinical evaluation report (CER)
Metered Dose Inhaler (MDI) Technology
13-14 Sep 2021 - London
Also on: 15 Sep 2021
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by David Howlett (bio)
New Medical Device Regulation
12-13 Oct 2021 - Online webinar
Also on: 14 Oct 2021
Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.
Pharmaceutical Development of ATMPs
4-5 Oct 2021 - Online webinar
Also on: 11 Oct 2021
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Presented by Andrew Willis (bio)
Pharmaceutical Packaging, Labelling and Artwork Origination
27-28 Oct 2021 - London
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
Pharmaceutical Regulatory Affairs in China
17-18 Nov 2021 - London
Also on: 24 Nov 2021
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
Pharmaceutical Regulatory Affairs in the Middle East
28-29 Jun 2021 - Online webinar
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Pharmacovigilance
21-23 Jun 2021 - Online webinar
Also on: 6 Dec 2021
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
Pharmacovigilance Aspects of Licensing Agreements
7 Oct 2021 - London
Also on: 8 Oct 2021
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Pharmacovigilance QMS & Inspection Preparation
16-17 Nov 2021 - London
Also on: 18 Nov 2021
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
Presented by Graeme Ladds (bio)
Positive Persuading and Influencing Skills for Pharma Professionals
16-17 Nov 2021 - Online webinar
Also on: 18 Nov 2021
This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business
Presented by Robert Hersowitz (bio)
Practical Implementation of GCP in Veterinary Field Studies
26-27 Oct 2021 - Online webinar
Also on: 28 Oct 2021
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.
Process Validation with Qualification
21-22 Sep 2021 - Online webinar
Also on: 23 Sep 2021
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)
Project Management for Pharma Professionals
9-10 Sep 2021 - Online webinar
Also on: 9 Dec 2021
The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health
*Includes:* Interactive workshop sessions
Presented by Laura Brown (bio)
Regulatory Affairs for Support Staff
27-28 Sep 2021 - Online webinar
Also on: 29 Sep 2021
This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.
Presented by Norah Lightowler (bio)
Regulatory Strategies for Orphan Drugs
22 Sep 2021 - Online webinar
Also on: 29 Sep 2021
This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Andrew Willis (bio)
Risk Management for Pharma and Biopharma Professionals
21 Sep 2021 - London
Also on: 23 Sep 2021
This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.
Presented by Laura Brown (bio)
Signal Detection and Regulatory Expectations
1-2 Nov 2021 - Online webinar
Also on: 3 Nov 2021
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)
Stability Testing of Pharmaceuticals and Biopharmaceuticals
12-13 Jul 2021 - Online webinar
Also on: 29 Nov 2021
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.
Successful Medical Writing
4-6 Oct 2021 - Online webinar
Also on: 11 Oct 2021
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.
Technical Documentation to Comply with the MDR and IVDR
22-23 Nov 2021 - London
Also on: 24 Nov 2021
This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.
The FDA Drug Approval Process
20-21 Sep 2021 - Online webinar
Also on: 27 Sep 2021
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Presented by Andrew Willis (bio)
The Medical Device Summer School - From Concept to CE Marking
5-9 Jul 2021 - Online webinar
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
The New EU Animal Health Legislation for Veterinary Medicinal Products
2-3 Nov 2021 - Online webinar
Also on: 4 Nov 2021
The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.
*INCLUDES: Interactive discussion sessions*
Presented by Julian Braidwood (bio)
The Pharma Mini MBA
10-12 Nov 2021 - Online webinar
Also on: 15 Nov 2021
A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries
Presented by Laura Brown (bio)
Variations to Marketing Authorisations
7-8 Oct 2021 - Online webinar
Also on: 14 Oct 2021
A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.
Presented by Andrew Willis (bio)
Veterinary Pharmaceutical Submissions in the EU
6-7 Dec 2021 - Online webinar
Also on: 8 Dec 2021
Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.
Presented by Julian Braidwood (bio)
Working Through Veterinary Drug Development in the EU and USA
21-25 Jun 2021 - Online webinar
This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.