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Pharmaceutical

A Practical Guide to Producing and Maintaining the PSMF Training Course

A Practical Guide to Producing and Maintaining the PSMF

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.

Presented by Graeme Ladds (bio)

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A Practical Guide to Writing Risk Management Plans (RMPs) Training Course

A Practical Guide to Writing Risk Management Plans (RMPs)

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.

Presented by Graeme Ladds (bio)

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Advanced Pharmacovigilance Training Course

Advanced Pharmacovigilance

17-19 Mar 2021 - Online webinar
Also on: 24 Mar 2021

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)

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An Essential Overview of Pharmacovigilance Training Course

An Essential Overview of Pharmacovigilance

26 Apr 2021 - Online webinar
Also on: 27 Apr 2021

A practical guide to understanding the role of pharmacovigilance.

Presented by Graeme Ladds (bio)

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An Essential Overview of the Medical Device Industry Training Course

An Essential Overview of the Medical Device Industry

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.

Presented by Theresa Jeary (bio)
David Jefferys (bio)

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An Essential Overview of the Pharmaceutical and Biotech Industries Training Course

An Essential Overview of the Pharmaceutical and Biotech Industries

6 May 2021 - London
Also on: 7 May 2021

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)

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An Introduction to Pharmaceutical Packaging Training Course

An Introduction to Pharmaceutical Packaging

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.

Presented by Chris Penfold (bio)

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Biosimilars Training Course

Biosimilars

23-24 Mar 2021 - Online webinar
Also on: 30 Mar 2021

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

NEW EVENT!

Presented by Andrew Willis (bio)

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Biotechnology for the Non-Biotechnologist Training Course

Biotechnology for the Non-Biotechnologist

14-16 Apr 2021 - Online webinar
Also on: 21 Apr 2021

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

Presented by Adrian Haines (bio)
and 6 more leading experts

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Borderlines between Medicines and Food Training Course

Borderlines between Medicines and Food

9 Dec 2021 - London
Also on: 10 Dec 2021

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

Presented by Penny Viner (bio)

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Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

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)

Presented by John Price (bio)

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Clinical Quality Management Systems Training Course

Clinical Quality Management Systems

17-18 May 2021 - Online webinar
Also on: 24 May 2021

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

Presented by Laura Brown (bio)

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Clinical Trial Regulatory Requirements Training Course

Clinical Trial Regulatory Requirements

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.

Presented by Laura Brown (bio)

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Common Technical Document Training Course

Common Technical Document

2-3 Jun 2021 - Online webinar
Also on: 9 Jun 2021

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

Presented by Andrew Willis (bio)

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Cyber Security for Medical Devices Training Course

Cyber Security for Medical Devices

19-20 Apr 2021 - London
Also on: 21 Apr 2021

Data Integrity and Document Management Training Course

Data Integrity and Document Management

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.

Presented by Laura Brown (bio)

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Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

5-6 May 2021 - Online webinar
Also on: 11 May 2021

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

Presented by Andrew Willis (bio)

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Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Drug/Device and Device/Drug Combinations in the EU and USA

26-27 Apr 2021 - London
Also on: 28 Apr 2021

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (bio)
and 3 more leading experts

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Dry Powder Inhalers Training Course

Dry Powder Inhalers

23-24 Jun 2021 - London

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design

*FULLY UPDATED PROGRAMME*

Presented by Mike Holroyd (bio)
David Howlett (bio)
Helen Muirhead (bio)

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Effective Technical Writing & Editing Training Course

Effective Technical Writing & Editing

11 Feb 2021 - Online webinar
Also on: 12 Feb 2021

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)

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Effective Technology Transfer Training Course

Effective Technology Transfer

20-21 Apr 2021 - Online webinar
Also on: 22 Apr 2021

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

Presented by Bruce Davis (bio)

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EU (European Union) Clinical Trial Regulation: Overview and Implementation Training Course

EU Clinical Trial Regulation: Overview and Implementation

20-21 Apr 2021 - London
Also on: 22 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

Presented by Laura Brown (bio)

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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

19-20 Apr 2021 - Online webinar
Also on: 21 Apr 2021

This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations

Presented by Norah Lightowler (bio)

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Filing eCTD Submissions Training Course

Filing eCTD Submissions

12 Apr 2021 - London
Also on: 13 Apr 2021

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

Presented by Justin Bailey (bio)
Jasbir Chohan (bio)

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GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course

GCP and Clinical Research Update - Hot Inspection Topics

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

Presented by Laura Brown (bio)

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How to Write Effective SOPs (Standard Operating Procedures) Training Course

How to Write Effective SOPs

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.

Presented by Laura Brown (bio)

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Improving Processes and CAPA (Corrective and Preventative Action) Training Course

Improving Processes and CAPA (Corrective and Preventative Action)

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.

Presented by Laura Brown (bio)

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Injectable Drug Delivery Training Course

Injectable Drug Delivery

10-11 Mar 2021 - London

Advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods.

Presented by Patrick Anquetil (bio)
and 6 more leading experts

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Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course

Managing Vendor/CRO/CMO Oversight

26-27 Apr 2021 - Online webinar
Also on: 28 Apr 2021

Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource

Presented by Laura Brown (bio)

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Metered Dose Inhaler (MDI) Technology Training Course

Metered Dose Inhaler (MDI) Technology

16-17 Feb 2021 - Online webinar
Also on: 18 Feb 2021

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Presented by David Howlett (bio)

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Nasal Drug Delivery Training Course

Nasal Drug Delivery

15-16 Apr 2021 - London

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

Presented by Michael Benninger (bio)
and 13 more leading experts

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Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

22-23 Mar 2021 - Online webinar
Also on: 29 Mar 2021

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

Presented by Andrew Willis (bio)
Alison Wilson (bio)

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Pharmaceutical Packaging, Labelling and Artwork Origination Training Course

Pharmaceutical Packaging, Labelling and Artwork Origination

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.

Presented by George Barrie (bio)
and 6 more leading experts

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Pharmaceutical Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

22-23 Mar 2021 - Online webinar
Also on: 24 Mar 2021

Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia and Zimbabwe.

Presented by Salma Ismail (bio)

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Pharmaceutical Regulatory Affairs in Asia Training Course

Pharmaceutical Regulatory Affairs in Asia

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

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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Pharmaceutical Regulatory Affairs in China Training Course

Pharmaceutical Regulatory Affairs in China

17-18 Nov 2021 - London
Also on: 24 Nov 2021

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

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

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.

Presented by Anna Harrington-Morozova (bio)

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Pharmaceutical Regulatory Affairs in the Middle East Training Course

Pharmaceutical Regulatory Affairs in the Middle East

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

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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Pharmacovigilance Training Course

Pharmacovigilance

21-23 Jun 2021 - London
Also on: 6 Dec 2021

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

Presented by Glyn Belcher (bio)
and 7 more leading experts

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Pharmacovigilance Aspects of Licensing Agreements Training Course

Pharmacovigilance Aspects of Licensing Agreements

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

Presented by Joanne Flitcroft (bio)
Carol Markwell (bio)

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Pharmacovigilance QMS & Inspection Preparation Training Course

Pharmacovigilance QMS & Inspection Preparation

11-12 May 2021 - London
Also on: 13 May 2021

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

Presented by Graeme Ladds (bio)

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Pre-Filled Syringes: End-to-End Processing Training Course

Pre-Filled Syringes: End-to-End Processing

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.

Presented by Dale Charlton (bio)
and 3 more leading experts

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Process Validation with Qualification Training Course

Process Validation with Qualification

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.

Presented by Bruce Davis (bio)

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Regulatory Affairs for Support Staff Training Course

Regulatory Affairs for Support Staff

16-17 Mar 2021 - London
Also on: 18 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.

Presented by Norah Lightowler (bio)

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Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

10 Mar 2021 - Online webinar
Also on: 17 Mar 2021

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

Presented by Andrew Willis (bio)

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Risk Management for Clinical Research Training Course

Risk Management for Clinical Research

22 Mar 2021 - Online webinar
Also on: 24 Mar 2021

Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures

Presented by Laura Brown (bio)

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Signal Detection and Regulatory Expectations Training Course

Signal Detection and Regulatory Expectations

4-5 May 2021 - Online webinar
Also on: 6 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

Presented by Graeme Ladds (bio)

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Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course

Stability Testing of Pharmaceuticals and Biopharmaceuticals

6-7 Jul 2021 - Online webinar
Also on: 8 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.

Presented by Ray Munden (bio)
Allan Watkinson (bio)

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Successful Medical Writing Training Course

Successful Medical Writing

17-19 May 2021 - London
Also on: 24 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.

Presented by Barry Drees (bio)
Barbara Grossman (bio)
James Visanji (bio)

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The end of the Brexit Transition Period – Impact on Pharmaceutical Industry Training Course

The end of the Brexit Transition Period – Impact on Pharmaceutical Industry

30 Nov 2020 - Online webinar

90 minute live webinar
13:00 (UK/London Time Zone)

Presented by David Jefferys (bio)

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The FDA (Food and Drug Administration) Drug Approval Process Training Course

The FDA Drug Approval Process

11-12 Mar 2021 - Online webinar
Also on: 18 Mar 2021

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)

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Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

25-26 Mar 2021 - Online webinar
Also on: 7 Apr 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.

Presented by Andrew Willis (bio)

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