Training courses & Webinars:
Pharmaceutical
By attending our pharmaceutical training courses you will gain access to industry, academic and regulatory authority experts with a wealth of experience. Our in-person events also provide the opportunity to network and discuss the challenges and developments with our speakers and other like-minded pharmaceutical professionals.
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 the industry. Our pharmaceutical training courses have been designed to focus on the latest developments and best practices, presented by industry experts on key topics across the pharmaceutical lifecycle, including clinical, regulatory, manufacturing, GxP, pharmacovigilance, medical writing and biopharma.
Please note: full product details will be shown on our training portal IPI Academy where you can find out more and book
A Practical Guide to Producing and Maintaining the PSMF
5 Aug 2024 - Online webinar
Also on: 10 Oct 2024
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)
1 Aug 2024 - Online webinar
Also on: 9 Oct 2024
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
Advanced Pharmacovigilance
5-7 Jun 2024 - Online webinar
Also on: 18 Sep 2024
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)
Agile Leadership for Pharma and Biopharma Professionals in a hybrid world
4-5 Jul 2024 - Online webinar
Also on: 18 Nov 2024
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 Medical Information
11 Jul 2024 - Online webinar
Also on: 29 Nov 2024
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
Presented by Graeme Ladds (bio)
An Essential Overview of Pharmacovigilance
9-10 Sep 2024 - Online webinar
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
An Essential Overview of the Medical Device Industry
8-9 Jul 2024 - Online webinar
Also on: 8 Nov 2024
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
10 May 2024 - Online webinar
Also on: 13 Sep 2024
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 Human Factors for Pharmaceutical and Medical Device Professionals
10 Jul 2024 - London
Also on: 23 Oct 2024
This course will cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.
Presented by Greg Thay (bio)
An Introduction to Pharmaceutical Packaging
20-22 May 2024 - Online webinar
Also on: 25 Sep 2024
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)
Best Practice for Writing Effective SOPs
18 Jul 2024 - Online webinar
Also on: 12 Dec 2024
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Laura Brown (bio)
Best Practices for Supplier Qualification in Life Science
15-16 Jul 2024 - Online webinar
Also on: 27 Nov 2024
Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.
Presented by Mustafa Edik (bio)
Biosimilars
10-11 Jul 2024 - Online webinar
Also on: 1 Oct 2024
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Presented by Andrew Willis (bio)
Biotechnology for the Non-Biotechnologist
24-28 Jun 2024 - Online webinar
Also on: 25 Sep 2024
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Presented by
Robert Alvarez (bio)
and 6 more leading experts
CAPA (Corrective and Preventative Action)
19 Jul 2024 - Online webinar
Also on: 13 Dec 2024
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement, and planning and implementation in process improvements and CAPA.
Presented by Laura Brown (bio)
Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products
27-28 Jun 2024 - Online webinar
Also on: 17 Oct 2024
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.
Presented by Andrew Willis (bio)
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
19-20 Jun 2024 - Online webinar
Also on: 2 Oct 2024
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)
Presented by John Price (bio)
Clinical Quality Management Systems
23-24 May 2024 - Online webinar
Also on: 19 Sep 2024
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Laura Brown (bio)
Clinical Research - A Different Approach to Successful Project Delivery
10 Jun 2024 - Online webinar
Also on: 4 Oct 2024
This Clinical Research Project Management Training course will provide you with key techniques to apply during your clinical research project to aid successful project delivery. This course will be key for those involved in clinical research projects and will cover system thinking, agile approaches and risk analysis.
Presented by Roger Joby (bio)
Clinical Trial Monitoring
29-30 Apr 2024 - Online webinar
Also on: 11 Jul 2024
This course will assure monitors understand the importance of compliance with latest ICH GCP R3 requirements, and how these apply to monitoring clinical trials in the future.
Presented by Laura Brown (bio)
Clinical Trial Regulatory Requirements
2-3 May 2024 - Online webinar
Also on: 16 Sep 2024
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 a brief review of key FDA requirements.
Presented by Laura Brown (bio)
Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration
18 Sep 2024 - Online webinar
An an excellent opportunity to hear from a renowned cognition expert and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes.
Presented by John E. Harrison (bio)
Consultative Selling for Pharma Professionals
13-14 May 2024 - Online webinar
Also on: 17 Sep 2024
In this two-day, selling for pharma professionals training course, Robert Hersowitz leads participants through a four step process guaranteed to foster influence and encourage commitment from clients.
Presented by Robert Hersowitz (bio)
Cosmetovigilance
20-21 Jun 2024 - Online webinar
Also on: 14 Oct 2024
This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW).
It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.
Presented by Graeme Ladds (bio)
Data Integrity and Document Management
22 Jul 2024 - Online webinar
Also on: 6 Dec 2024
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)
Data Integrity Auditor Master Class
24-25 Jul 2024 - Online webinar
Also on: 16 Oct 2024
During this course data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed.
Presented by Mustafa Edik (bio)
Delivery of Biologics to the Nasal Cavity
4 Jun 2024 - Online webinar
Also on: 8 Oct 2024
The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.
Presented by
Gemma Budd (bio)
and 3 more leading experts
Development of Combination Products: Critical Interactions
25-26 Jun 2024 - Online webinar
Also on: 3 Oct 2024
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Presented by Andrew Willis (bio)
Drug Discovery: A Step-by-Step Introduction
23-24 Sep 2024 - Online webinar
This drug discovery training course takes you on a science-based drug discovery journey. You will travel from inception of a new project to the point of hand-over of the newly discovered molecule to the Drug Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted drug discovery process into individual steps which build towards this key goal. The focus is on how essential science, technology and infrastructure elements are constituted, deployed and integrated to maximise the likelihood of a successful drug discovery project.
Presented by Peter A. Lowe (bio)
Effective Technical Writing & Editing
28 Jun 2024 - Online webinar
Also on: 1 Oct 2024
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
16-17 Jul 2024 - Online webinar
Also on: 7 Oct 2024
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
Effective Training Skills in the Pharma Industry
13-14 Jun 2024 - Online webinar
Also on: 10 Oct 2024
This interactive training skills and processes in pharma course is ideal for anyone with responsibility for planning or delivering training in the pharma, device or animal health industries (includes face-to-face and virtual training).
Presented by Laura Brown (bio)
EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience
20-21 May 2024 - Online webinar
Also on: 25 Jul 2024
This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.
Presented by Laura Brown (bio)
EU Pharmaceutical Regulations & Strategy
10-11 Jun 2024 - Online webinar
Also on: 14 Oct 2024
The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.
Presented by Norah Lightowler (bio)
EU Proposed Pharmaceutical Legislation Changes
22 May 2024 - Online webinar
Also on: 18 Sep 2024
On 26 April 2023, the European Commission proposed a new directive and regulation to revise and replace current pharmaceutical legislation.
This course will provide an up-to-date overview of current European pharmaceutical legislation and the proposed changes. The potential regulatory impact of the proposed changes on company planning and strategy will be considered and discussed.
Presented by Norah Lightowler (bio)
European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications
15-17 Jul 2024 - Online webinar
Also on: 4 Nov 2024
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.
Presented by Graeme Ladds (bio)
GCP and Clinical Research Update - Hot Inspection Topics
1 Jul 2024 - Online webinar
Also on: 22 Nov 2024
This course provides recent updates on the New ICH GCP R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.
Presented by Laura Brown (bio)
Global Pharmaceutical Regulatory Affairs Summer School
10-14 Jun 2024 - Online webinar
Unlock the world of pharmaceutical regulatory excellence with our Global Pharmaceutical Regulatory Affairs training – an intensive journey through the diverse regions, offering practical insights, expert guidance, and strategic mastery for professionals seeking to navigate and succeed in the dynamic global regulatory landscape.
Presented by
Alan Chalmers (bio)
and 8 more leading experts
Good Distribution Practices of Pharmaceuticals and APIs
22-23 Jul 2024 - Online webinar
Also on: 14 Nov 2024
Gain a comprehensive understanding of industry-leading practices, ensuring precision in distribution from manufacturer to end user. Navigate complex supply chains, focus on compliance, and elevate your commitment to quality assurance throughout the entire distribution process.
Presented by Mustafa Edik (bio)
ICH Q9(R1) Quality Risk Management (QRM)
1 May 2024 - Online webinar
Also on: 25 Sep 2024
ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.
Presented by Bruce Davis (bio)
Managing Service Providers including CRO and CMOs oversight to comply with ICH GCP R3
24-25 Jun 2024 - Online webinar
Also on: 17 Oct 2024
Optimising oversight for inspection compliance
Presented by Laura Brown (bio)
MBA Strategic Thinking for Pharma and Biopharma Professionals
15-16 Jul 2024 - Online webinar
Also on: 3 Oct 2024
Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure, is probably one of the most challenging managerial roles of any industry today.
Presented by Laura Brown (bio)
Metrics and Earned Value in Clinical Research Projects
11 Jul 2024 - Online webinar
Also on: 25 Nov 2024
This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. A valuable master class for anyone involved in clinical research.
Presented by Roger Joby (bio)
New EU GMP Annex 1: Compliant Aseptic Operations
2-4 Jul 2024 - Online webinar
Also on: 26 Nov 2024
Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety.
During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.
Presented by Mustafa Edik (bio)
Pharmaceutical Development of ATMPs
18-19 Jun 2024 - Online webinar
Also on: 14 Oct 2024
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 Regulatory Affairs in Africa
17-18 Jun 2024 - Online webinar
Also on: 19 Nov 2024
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
Pharmaceutical Regulatory Affairs in Asia
12-14 Jun 2024 - Online webinar
Also on: 9 Oct 2024
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
29-30 Apr 2024 - Online webinar
Also on: 2 Jul 2024
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
Pharmaceutical Regulatory Affairs in Latin America
19 Jun 2024 - Online webinar
Also on: 22 Oct 2024
This programme offers a detailed examination of the regulatory landscape, emphasizing both challenges and opportunities for the pharmaceutical industry across key Latin American markets, including Argentina, Brazil, Chile, Colombia, Mexico, and Peru.
Presented by Belkys Ruiz (bio)
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
24-25 Jun 2024 - Online webinar
Also on: 3 Oct 2024
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
Presented by Anna Harrington-Morozova (bio)
Pharmaceutical Regulatory Affairs in the Middle East
26-27 Jun 2024 - Online webinar
Also on: 9 Dec 2024
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Pharmacovigilance Aspects of Licensing Agreements
10 Jul 2024 - Online webinar
Also on: 27 Nov 2024
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 - Broadening your Knowledge
30 Sep-2 Oct 2024 - Online webinar
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.
Presented by Graeme Ladds (bio)
Pharmacovigilance QMS & Inspection Preparation
20-21 May 2024 - Online webinar
Also on: 26 Sep 2024
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
29-30 Jul 2024 - Online webinar
Also on: 11 Nov 2024
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 Requirements of the Arab Pharmacovigilance Guidelines
13-14 Jun 2024 - Online webinar
Also on: 17 Oct 2024
Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East
Presented by Graeme Ladds (bio)
Process Validation with Qualification
21-22 May 2024 - Online webinar
Also on: 23 Sep 2024
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
17-18 Jun 2024 - Online webinar
Also on: 26 Sep 2024
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
24-25 Sep 2024 - Online webinar
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
24 Jun 2024 - Online webinar
Also on: 8 Oct 2024
This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Shaun Stapleton (bio)
Risk Management for Pharma and Biopharma Professionals
7 Jun 2024 - Online webinar
Also on: 8 Oct 2024
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)
Root Cause Analysis and Critical Thinking
23 Jul 2024 - Online webinar
Also on: 25 Nov 2024
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)
Signal Detection and Regulatory Expectations
1-2 Jul 2024 - Online webinar
Also on: 12 Nov 2024
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)
Smart Packaging and Electronic Patient Information
10 Jul 2024 - Online webinar
Also on: 4 Nov 2024
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.
Presented by Graham Howieson (bio)
Stability Testing of Pharmaceuticals and Biopharmaceuticals
11-12 Jul 2024 - Online webinar
Also on: 11 Nov 2024
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 – from Protocol to CTD
27-29 Nov 2024 - Online webinar
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 Common Technical Document
8-9 Jul 2024 - Online webinar
Also on: 25 Nov 2024
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Presented by Andrew Willis (bio)
The Common Technical Document (CTD) Submission in the MENA Region
10 Jul 2024 - Online webinar
Also on: 28 Nov 2024
This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.
Presented by Mohammad Fat'hy Elnadi (bio)
The FDA Drug Approval Process
12-13 Jun 2024 - Online webinar
Also on: 2 Dec 2024
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 Leadership and Management Summer School for Pharma Professionals
29 Jul-2 Aug 2024 - Online webinar
Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure, is probably one of the most challenging managerial roles of any industry today. This 5-day Summer School has been especially designed to help you transcend these challenges by training you to become equipped to see the bigger picture in all aspects of your role.
Presented by
Leela Barham (bio)
and 3 more leading experts
The Pharma Mini MBA
15-17 May 2024 - Online webinar
Also on: 31 Jul 2024
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
Understanding Active Pharmaceutical Ingredients (APIs)
17-18 Jul 2024 - Online webinar
Also on: 18 Nov 2024
This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.
Understanding and Interpreting the Proposed Changes to EU GMP Annex 11
17 Sep 2024 - Online webinar
Also on: 21 Jan 2025
This half-day course will provide an essential update on the proposed changes to EU GMP Annex 11 and will enhance delegate's understanding of the implications on working practices, as well as including a control framework for AI and ML.
Presented by Bob McDowall (bio)
Understanding Computer System Validation (CSV)
24-25 Jul 2024 - Online webinar
Also on: 25 Nov 2024
This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5). It will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.
Understanding Pharmacovigilance Regulations in APAC
8-9 Jul 2024 - Online webinar
Also on: 8 Oct 2024
Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.
Presented by
Param Dayal (bio)
and 4 more leading experts
US FDA - Understanding Key Factors When Working with the FDA
12 Jul 2024 - Online webinar
Also on: 27 Nov 2024
This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration). For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.
Presented by Andrew Willis (bio)
Variations to Marketing Authorisations
10-11 Jun 2024 - Online webinar
Also on: 28 Nov 2024
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)
Working with Emotional Intelligence in the Pharmaceutical and Biopharma Industry
21 Jun 2024 - Online webinar
Also on: 14 Oct 2024
This emotional intelligence in pharma and biopharma straining course will help you learn to communicate more effectively in the pharma and biopharma industries.
"What really matters for success, character, happiness and life long achievements is a definite set of emotional skills – your EQ — not just purely cognitive abilities that are measured by IQ tests.” — Daniel Goleman
Presented by Laura Brown (bio)