A Practical Guide to Producing and Maintaining the PSMF Training Course
29 Jan 2021 - Online webinar
Also on: 5 Feb 2021
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) Training Course
28 Jan 2021 - Online webinar
Also on: 4 Feb 2021
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Advanced Pharmacovigilance Training Course
An Essential Overview of Pharmacovigilance Training Course
An Essential Overview of the Medical Device Industry Training Course
13 May 2021 - Online webinar
Also on: 14 May 2021
This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.
An Essential Overview of the Pharmaceutical and Biotech Industries Training Course
23 Oct 2020 - Online webinar
Also on: 6 May 2021
This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.
An Introduction to Pharmaceutical Packaging Training Course
15-16 Mar 2021 - London
Also on: 17 Mar 2021
This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.
Biosimilars Training Course
Biotechnology for the Non-Biotechnologist Training Course
30 Sep-2 Oct 2020 - Online webinar
Also on: 14 Apr 2021
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Borderlines between Medicines and Food Training Course
10 Dec 2020 - London
Also on: 11 Dec 2020
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
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course
30 Mar 2021 - Online webinar
Also on: 31 Mar 2021
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)
Clinical Quality Management Systems Training Course
Clinical Trial Regulatory Requirements Training Course
26-27 Jan 2021 - London
Also on: 28 Jan 2021
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.
Common Technical Document Training Course
Cyber Security for Medical Devices Training Course
Data Integrity and Document Management Training Course
4 Mar 2021 - London
Also on: 5 Mar 2021
Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.
Development of Combination Products: Critical Interactions Training Course
17-18 Nov 2020 - Online webinar
Also on: 5 May 2021
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course
24-25 Sep 2020 - Online webinar
Also on: 26 Apr 2021
Practical guidance on borderline Issues and combination products
Dry Powder Inhalers Training Course
Effective Technical Writing & Editing Training Course
Effective Technology Transfer Training Course
EU (European Union) Clinical Trial Regulation: Overview and Implementation Training Course
19-20 Oct 2020 - Online webinar
Also on: 20 Apr 2021
This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU
EU (European Union) Pharmaceutical Regulations & Strategy Training Course
Filing eCTD Submissions Training Course
GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course
23 Mar 2021 - Online webinar
Also on: 25 Mar 2021
This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented
How to Write Effective SOPs (Standard Operating Procedures) Training Course
3 Dec 2020 - Online webinar
Also on: 28 Jun 2021
An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.
Improving Processes and CAPA (Corrective and Preventative Action) Training Course
4 Dec 2020 - Online webinar
Also on: 29 Jun 2021
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.
Injectable Drug Delivery Training Course
Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course
Metered Dose Inhaler (MDI) Technology Training Course
Nasal Drug Delivery Training Course
Pharmaceutical Development of ATMPs Training Course
Pharmaceutical Packaging, Labelling and Artwork Origination Training Course
27-28 Oct 2021 - London
This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.
Pharmaceutical Regulatory Affairs in Africa Training Course
12-13 Oct 2020 - Online webinar
Also on: 22 Mar 2021
Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia, Zimbabwe and French-speaking Africa
Pharmaceutical Regulatory Affairs in Asia Training Course
7-9 Apr 2021 - Online webinar
Also on: 14 Apr 2021
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 Training Course
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course
2-3 Feb 2021 - London
Also on: 4 Feb 2021
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 Training Course
28-29 Jun 2021 - Online webinar
Also on: 5 Jul 2021
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Pharmacovigilance Training Course
Pharmacovigilance Aspects of Licensing Agreements Training Course
15 Apr 2021 - Online webinar
Also on: 16 Apr 2021
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Pharmacovigilance QMS & Inspection Preparation Training Course
Pre-Filled Syringes: End-to-End Processing Training Course
23-24 Mar 2021 - Online webinar
Also on: 25 Mar 2021
Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
Process Validation with Qualification Training Course
2-3 Mar 2021 - Online webinar
Also on: 4 Mar 2021
Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.
Regulatory Affairs for Support Staff Training Course
29-30 Sep 2020 - Online webinar
Also on: 16 Mar 2021
This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.
Regulatory Strategies for Orphan Drugs Training Course
Risk Management for Clinical Research Training Course
Signal Detection and Regulatory Expectations Training Course
2-3 Nov 2020 - Online webinar
Also on: 4 May 2021
This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement
Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course
2-3 Dec 2020 - Online webinar
Also on: 6 Jul 2021
Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.
Successful Medical Writing Training Course
5-7 Oct 2020 - Online webinar
Also on: 17 May 2021
Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.
The FDA (Food and Drug Administration) Drug Approval Process Training Course
Variations to Marketing Authorisations Training Course
8-9 Oct 2020 - Online webinar
Also on: 25 Mar 2021
A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.