Pharmaceutical Training Courses

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.

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.

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.

Agile Leadership for Pharma and Biopharma Professionals in a virtual world

Live online, Classroom
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

An Essential Overview of Medical Information

Live online, Classroom
Focused

In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring

An Essential Overview of Pharmacovigilance

Live online, Classroom
Focused

A practical guide to understanding the role of pharmacovigilance.

An Introduction to Quality Management for Managers

New for 2022

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.

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.

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

New for 2022

Live online, Classroom
Focused

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

Clinical Quality Management Systems

Live online, Classroom
Focused

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

Clinical Trial Regulatory Requirements

Live online, Classroom
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.

Data Integrity and Document Management

Live online, Classroom
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.

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

Drafting Commercial Contracts for the Pharmaceutical Industry

Live online, Classroom
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.

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.

Effective Technology Transfer

Live online, Classroom
Focused

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

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

EU Pharmaceutical Regulations & Strategy

Live online, Classroom
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.

European Post Marketing Pharmacovigilance

New for 2022

Live online, Classroom
Focused

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

GCP and Clinical Research Update - Hot Inspection Topics

Live online, Classroom
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

GMP Fundamentals

New for 2022

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.

Managing Vendor/CRO/CMO Oversight

Live online, Classroom
Focused

Optimising oversight for inspection compliance

MBA Strategic Thinking for Pharma and Biopharma Professionals

Live online, Classroom
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.

Pharmaceutical Development of ATMPs

Live online, Classroom
Focused

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

Pharmaceutical Regulatory Affairs in Asia

Live online, Classroom
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

Pharmaceutical Regulatory Affairs in China

Live online, Classroom
Focused

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

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

Live online, Classroom
Focused

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

Pharmaceutical Regulatory Affairs in the Middle East

Live online, Classroom
Focused

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

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.

Pharmacovigilance Aspects of Licensing Agreements

Live online, Classroom
Focused

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

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors

New for 2022

Live online, Classroom
Focused

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.

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.

Project Management for Pharma Professionals

Live online, Classroom
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

Quality Management Refresher

New for 2023

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.

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.

Root Cause Analysis (RCA) and Critical Thinking

New for 2022

Live online, Classroom
Focused

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

Signal Detection and Regulatory Expectations

Live online, Classroom
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

Smart Packaging and Electronic Patient Information

New for 2023

Live online, 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.

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Live online, Classroom
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.

Successful Medical Writing

Live online, Classroom
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.

The Pharma Mini MBA

Live online, Classroom
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