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In-house & bespoke training:
Pharmaceutical

Discovery, development and manufacture of drugs are central to the pharmaceutical industry. Keeping up to date with the latest regulations and new discoveries in this fast-paced environment is essential for all professionals working within this industry. Our pharmaceutical industry training courses have been designed to focus on latest developments and best practice, presented by industry experts on key topics across the pharmaceutical lifecycle, including clinical, regulatory, pharmacovigilance, medical writing and biopharma.

By attending our pharmaceutical industry training courses online or in person, you will also gain the opportunity to network and discuss topics with other like-minded pharmaceutical professionals.

 

A Practical Guide to Producing and Maintaining the PSMF

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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A Practical Guide to Writing Risk Management Plans (RMPs)

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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Advanced Pharmacovigilance

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 3 days
Pricing from £1,200 per attendee
Delivery: collaborative classroom

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Agile Leadership for Pharma and Biopharma Professionals in a virtual world

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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An Essential Overview of Pharmacovigilance

In-house & bespoke training

A practical guide to understanding the role of pharmacovigilance.

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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An Essential Overview of the Medical Device Industry

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Theresa Jeary (bio) , David Jefferys (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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An Essential Overview of the Pharmaceutical and Biotech Industries

In-house & bespoke training

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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An Introduction to Pharmaceutical Packaging

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Chris Penfold (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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An Introduction to Quality Management for Managers

In-house & bespoke training

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.

Typically presented by Rob Hughes (bio)

Delivery: collaborative classroom

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Best Practice for Writing Effective SOPs

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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Biosimilars

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Hans van Bruggen (bio) , Marloes van der Geer (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Biotechnology for the Non-Biotechnologist

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Robert Alvarez (bio)
and 6 more leading experts

Typical duration: 3 days
Pricing from £1,200 per attendee
Delivery: collaborative classroom

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Borderlines between Medicines and Food

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Brian Kelly (bio) , Penny Viner (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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CAPA (Corrective and Preventative Action)

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

In-house & bespoke training

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)

Rated by attendees to the public programme

Typically presented by John Price (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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Clinical Quality Management Systems

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Clinical Trial Monitoring

In-house & bespoke training

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.

Typically presented by Laura Brown (bio)

Delivery: collaborative classroom

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Clinical Trial Regulatory Requirements

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Data Integrity and Document Management

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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Development of Combination Products: Critical Interactions

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by David Howlett (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Drafting and Negotiating Clinical Trial Agreements

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Alex Denoon (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Drafting Commercial Contracts for the Pharmaceutical Industry

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by James Agnew (bio)
and 13 more leading experts

Typical duration: 3 days
Pricing from £1,200 per attendee
Delivery: collaborative classroom

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Effective Technical Writing & Editing

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Barbara Grossman (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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Effective Technology Transfer

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Bruce Davis (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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EU Clinical Trial Regulation 536/2014: Overview and Implementation

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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EU Pharmaceutical Regulations & Strategy

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Norah Lightowler (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Filing eCTD Submissions

In-house & bespoke training

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

Typically presented by Maikel Bouman (bio) , Marloes van der Geer (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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GCP and Clinical Research Update - Hot Inspection Topics

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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GMP Fundamentals

In-house & bespoke training

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.

Typically presented by Rob Hughes (bio)

Typical duration: 2 days
Delivery: collaborative classroom

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Managing Vendor/CRO/CMO Oversight

In-house & bespoke training

Optimising oversight for inspection compliance

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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MBA Strategic Thinking for Pharma and Biopharma Professionals

In-house & bespoke training

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.

Typically presented by Laura Brown (bio)

Delivery: collaborative classroom

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Pharmaceutical Development of ATMPs

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Andrew Willis (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Pharmaceutical Packaging, Labelling and Artwork Origination

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by George Barrie (bio)
and 6 more leading experts

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Pharmaceutical Regulatory Affairs in Africa

In-house & bespoke training

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

Rated by attendees to the public programme

Typically presented by Salma Ismail (bio) , Makram Nehme (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Pharmaceutical Regulatory Affairs in Asia

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Alan Chalmers (bio) , Monica Dressler-Meyer (bio)

Typical duration: 3 days
Pricing from £1,200 per attendee
Delivery: collaborative classroom

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Pharmaceutical Regulatory Affairs in China

In-house & bespoke training

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

Rated by attendees to the public programme

Typically presented by Alan Chalmers (bio) , Monica Dressler-Meyer (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

In-house & bespoke training

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

Rated by attendees to the public programme

Typically presented by Anna Harrington-Morozova (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Pharmaceutical Regulatory Affairs in the Middle East

In-house & bespoke training

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

Rated by attendees to the public programme

Typically presented by Heba Hashem (bio) , Ilona Putz (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Pharmacovigilance

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Glyn Belcher (bio)
and 5 more leading experts

Typical duration: 3 days
Pricing from £1,200 per attendee
Delivery: collaborative classroom

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Pharmacovigilance Aspects of Licensing Agreements

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Joanne Flitcroft (bio) , Graeme Ladds (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Pharmacovigilance QMS & Inspection Preparation

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Positive Persuading and Influencing Skills for Pharma Professionals

In-house & bespoke training

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

Rated by attendees to the public programme

Typically presented by Robert Hersowitz (bio)

Typical duration: 3 days
Pricing from £1,200 per attendee
Delivery: collaborative classroom

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Practical Requirements of the Arab Pharmacovigilance Guidelines

In-house & bespoke training

Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East

Typically presented by Graeme Ladds (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Process Validation with Qualification

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Bruce Davis (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Project Management for Pharma Professionals

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Quality Management Refresher

In-house & bespoke training

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.

Typically presented by Rob Hughes (bio)

Typical duration: 1 day
Delivery: collaborative classroom

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Regulatory Affairs for Support Staff

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Norah Lightowler (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Regulatory Strategies for Orphan Drugs

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Marloes van der Geer (bio)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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Risk Management for Pharma and Biopharma Professionals

In-house & bespoke training

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.

Typically presented by Laura Brown (bio)

Delivery: collaborative classroom

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Root Cause Analysis and Critical Thinking

In-house & bespoke training

This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals

Typically presented by Laura Brown (bio)

Delivery: collaborative classroom

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Signal Detection and Regulatory Expectations

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Graeme Ladds (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Smart Packaging and Electronic Patient Information

In-house & bespoke training

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.

Typically presented by Christopher Waterhouse (bio)

Delivery: collaborative classroom

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Stability Testing of Pharmaceuticals and Biopharmaceuticals

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Paul Palmer (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Successful Medical Writing

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Barry Drees (bio) , Barbara Grossman (bio) , James Visanji (bio)

Typical duration: 3 days
Pricing from £1,200 per attendee
Delivery: collaborative classroom

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The Common Technical Document

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Hans van Bruggen (bio) , Marloes van der Geer (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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The FDA Drug Approval Process

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Hans van Bruggen (bio) , Marloes van der Geer (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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The Pharma Mini MBA

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Laura Brown (bio)

Typical duration: 4 days
Pricing from £1,400 per attendee
Delivery: collaborative classroom

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Variations to Marketing Authorisations

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Joanne Roza (bio) , Marloes van der Geer (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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It was a very useful training that fulfil my necessities about the Industry standards for the Technology transfers... Bruce is very knowledgeable and he was continuously asking the participants to provide feedback and their own experiences.

Sergio Molina Zaragoza, Vice President Research and Development, Grifols Biologicals LLC

Excellent would attend other similar webinar/trainings

Cheryl Dicks, Sr. Mgr. Regulatory, CANbridge Pharmaceuticals

Very engaging with lots of examples to ease understanding.

Kirsty Brown, Scientist II, Thermo Fisher Scientific

Very good presentation and useful information with links, examples and clips which made it more interesting.

Kianoosh Khaksar, Compliance Specialist, Lundbeck

The level of detail and complexity was just right and I have learnt a lot and would certainly recommend this course to others. I thoroughly enjoyed the course.

Melanie Pires, Pharmaceutical Assessor, Medicines and Healthcare Products Regulatory Agency (MHRA)

I was hoping to achieve more knowledge about combination product and the regulatory documentations needed for the market authorisation and this was completely accomplished.

Greta Ferrari, Analytical Scientist, Chiesi Farmaceutici

Understanding RFP and RFI were achieved, KPI session was very helpful and I learnt about oversight plan which I never knew about... Laura was very good, provided great content of the subject matter and discussions included were good and relevant.

Stephanie Yearwood, Senior Vendor Management Coordinator , IQVIA

I learned a lot about Risk Qualification and Validation. It helps me understand my role in Facilities Qualification.

Morady Som, Facilities Qualification , Cepheid

The webinar was very good overall with very comprehensive material and understandable throughout. The speakers were very knowledgeable and were open to questions and comments and answered them very professionally.

Tomas Orn Sigurbjornsson, Sourcing Lead, Alvotech

I did get some interesting information that may be useful when writing these documents in the future.

Nele Hilgert, Medical Writer, Emtex Life Science