- 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: 29-30 Sep 2022 Live online
Agile Leadership for Pharma and Biopharma Professionals in a virtual world
Live online
Focused
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
- 12 CPD hours
-
Presented by Dr Laura Brown
- 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: 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: 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: 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: 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: 1 Aug 2022 Classroom
- Also: 4 Nov 2022 Live online
Drafting and Negotiating Clinical Trial Agreements
Live online, Classroom
Focused
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
- 6 CPD hours
-
Presented by Alex Denoon
- Next: 23-25 Nov 2022 Live online
Drafting Commercial Contracts for the Pharmaceutical Industry
Live online
Focused
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.
- 18 CPD hours
-
Presented by Graham Roberts-Phelps
-
+ 10 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: 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: 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: 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: 12-13 Sep 2022 Live online
MBA Strategic Thinking for Pharma and Biopharma Professionals
Live online
Focused
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.
- 12 CPD hours
-
Presented by Dr Laura Brown
- 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: 13-14 Jul 2022 Live online
- Also: 14-15 Nov 2022 Live online
Positive Persuading and Influencing Skills for Pharma Professionals
Live online
Focused
This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business
- 12 CPD hours
-
Presented by Mr Robert Hersowitz
- 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: 20-21 Jun 2022 Live online
- Also: 8-9 Sep 2022 Live online
- Also: 8-9 Dec 2022 Live online
Project Management for Pharma Professionals
Live online
Focused
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
- 12 CPD hours
-
Presented by Dr Laura Brown
- 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: 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: 21 Nov 2022 Live online
Root Cause Analysis (RCA) and Critical Thinking
Live online
Focused
This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals
- 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: 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
- 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
-
and Marloes van der Geer
- Self-paced
The Pharma 'Mini-MBA' On-line Learning Programme
Self-paced
A 14 module self-managed, flexible, online learning course: Focus on the essential MBA theory, practice and technique needed to be a high-performing manager in the field of pharmaceutical with this 14 module course allowing 3 to 4 hours per module to be completed in your own time.
-
Mark Thomas
-
+ 6 more
- Next: 18-20 May 2022 Live online
- Also: 9-11 Nov 2022 Live online
The Pharma Mini MBA
Live online
Focused
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
- 18 CPD hours
-
Presented by Dr Laura Brown
-
+ 2 more
- 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.
-
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