Life Sciences

A Practical Approach to Veterinary Vaccine Development and Registration in the EU

9-10 Mar 2021 - Online webinar

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

A Practical Guide to Producing and Maintaining the PSMF

29 Jan 2021 - Online webinar
Also on: 29 Jun 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)

28 Jan 2021 - Online webinar
Also on: 28 Jun 2021

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

A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China

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

Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.

Advanced Pharmacovigilance

17-19 Mar 2021 - Online webinar
Also on: 22 Sep 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.

Advanced Regulatory Affairs for Medical Devices

20-21 Apr 2021 - Online webinar
Also on: 28 Sep 2021

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

Advanced Veterinary Pharmacovigilance

21-22 Jun 2021 - London
Also on: 23 Jun 2021

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

An Essential Overview of Pharmacovigilance

26 Apr 2021 - Online webinar
Also on: 4 Oct 2021

A practical guide to understanding the role of pharmacovigilance.

An Essential Overview of the Medical Device Industry

13 May 2021 - Online webinar
Also on: 18 Oct 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

7 May 2021 - Online webinar
Also on: 16 Sep 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

17-18 Mar 2021 - Online webinar
Also on: 28 Sep 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.

An Introduction to the Design and Development of Medical Devices

24-25 May 2021 - Online webinar
Also on: 11 Oct 2021

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

An Introduction to the Medical Device Regulation

12-14 May 2021 - Online webinar
Also on: 10 Nov 2021

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Biological Evaluation of Medical Devices

18-19 May 2021 - London
Also on: 23 Nov 2021

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.

*Includes:* Interactive workshops and discussion sessions

Biosimilars

23-24 Mar 2021 - Online webinar
Also on: 5 Oct 2021

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

NEW EVENT!

Biotechnology for the Non-Biotechnologist

14-16 Apr 2021 - Online webinar
Also on: 29 Sep 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

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

CAPA (Corrective and Preventative Action)

29 Jun 2021 - Online webinar
Also on: 3 Dec 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.

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

8-9 Jun 2021 - Online webinar
Also on: 29 Nov 2021

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

30 Mar 2021 - Online webinar

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

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

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

Clinical Trial Regulatory Requirements

28-29 Jan 2021 - Online webinar
Also on: 5 Jul 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

2-3 Jun 2021 - Online webinar
Also on: 29 Nov 2021

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

Cyber Security for Medical Devices

21-22 Apr 2021 - Online webinar

Data Integrity and Document Management

5 Mar 2021 - Online webinar
Also on: 4 Oct 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

5-6 May 2021 - Online webinar
Also on: 9 Nov 2021

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

Drafting and Negotiating Clinical Trial Agreements

26 Feb 2021 - Online webinar
Also on: 10 Jun 2021

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

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

28-29 Apr 2021 - Online webinar

Practical guidance on borderline Issues and combination products

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*

Effective Technical Writing & Editing

11 Feb 2021 - Online webinar
Also on: 23 Sep 2021

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

Effective Technology Transfer

20-21 Apr 2021 - Online webinar
Also on: 5 Oct 2021

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

EU Clinical Trial Regulation: Overview and Implementation

22-23 Apr 2021 - Online webinar
Also on: 18 Oct 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 Pharmaceutical Regulations & Strategy

19-20 Apr 2021 - Online webinar
Also on: 18 Oct 2021

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

FDA Approval Process for Medical Devices

24-25 Mar 2021 - Online webinar
Also on: 13 Sep 2021

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Filing eCTD Submissions

13 Apr 2021 - Online webinar
Also on: 18 Oct 2021

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

GCP and Clinical Research Update - Hot Inspection Topics

23 Mar 2021 - Online webinar
Also on: 22 Sep 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

28 Jun 2021 - Online webinar
Also on: 2 Dec 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.

Human Factors and Usability Engineering in the Development of Drug Delivery Products

23-24 Feb 2021 - Online webinar
Also on: 20 Sep 2021

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

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.

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

11-12 May 2021 - Online webinar
Also on: 2 Nov 2021

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Introduction to Veterinary Pharmacovigilance

20-21 Apr 2021 - Online webinar
Also on: 12 Oct 2021

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

*INCLUDES: Interactive workshop and discussion sessions*

Managing Vendor/CRO/CMO Oversight

26-27 Apr 2021 - Online webinar
Also on: 7 Oct 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

Medical Device Regulation in the Eurasian Union, Russia and the CIS

6-7 Oct 2021 - Online webinar
Also on: 13 Oct 2021

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

Medical Device Regulations in the Middle East and North Africa

30 Jun-1 Jul 2021 - Online webinar

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

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

Medical Device Software: Complying with the MDR & FDA Regulations

28-30 Apr 2021 - Online webinar
Also on: 27 Oct 2021

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Medical Device Studies: Clinical Evidence

10-11 May 2021 - Online webinar
Also on: 8 Nov 2021

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

23-24 Feb 2021 - Online webinar
Also on: 20 Sep 2021

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Medical Writing for Medical Devices

3-4 Mar 2021 - Online webinar
Also on: 19 Oct 2021

How to produce quality regulatory documents including the clinical evaluation report (CER)

Metered Dose Inhaler (MDI) Technology

1-2 Mar 2021 - Online webinar
Also on: 13 Sep 2021

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

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.

New Medical Device Regulation

17-18 Mar 2021 - Online webinar
Also on: 12 Oct 2021

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Periodic Safety Update Reports for Veterinary Medicinal Products

11-12 May 2021 - Online webinar
Also on: 19 Oct 2021

Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit

*NEW EVENT!*

Pharmaceutical Development of ATMPs

22-23 Mar 2021 - Online webinar
Also on: 4 Oct 2021

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

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.

Pharmaceutical Regulatory Affairs in Africa

22-23 Mar 2021 - Online webinar

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

Pharmaceutical Regulatory Affairs in Asia

7-9 Apr 2021 - Online webinar

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

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.

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

4-5 Feb 2021 - Online webinar

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

28-29 Jun 2021 - Online webinar

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

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.

Pharmacovigilance Aspects of Licensing Agreements

15 Apr 2021 - Online webinar
Also on: 7 Oct 2021

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

Pharmacovigilance QMS & Inspection Preparation

13-14 May 2021 - Online webinar
Also on: 16 Nov 2021

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

Practical Implementation of GCP in Veterinary Field Studies

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

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

Pre-Filled Syringes: End-to-End Processing

23-24 Mar 2021 - Online webinar

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

2-3 Mar 2021 - Online webinar
Also on: 21 Sep 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.

Registration of Animal Feed Additives in the EU

16-17 Jun 2021 - Online webinar

This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

Registration of Veterinary Vaccines in the USA and Canada

11 Mar 2021 - Online webinar

This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.

Regulatory Affairs for Support Staff

18-19 Mar 2021 - Online webinar
Also on: 27 Sep 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

10 Mar 2021 - Online webinar
Also on: 22 Sep 2021

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

Risk Management for Clinical Research

22 Mar 2021 - Online webinar
Also on: 21 Sep 2021

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

Signal Detection and Regulatory Expectations

4-5 May 2021 - Online webinar
Also on: 1 Nov 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

6-7 Jul 2021 - Online webinar
Also on: 29 Nov 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

24-26 May 2021 - Online webinar
Also on: 4 Oct 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.

Technical Documentation to Comply with the MDR and IVDR

10-11 Mar 2021 - Online webinar
Also on: 22 Nov 2021

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

The end of the Brexit Transition Period – Impact on Medical Device Industry

25 Jan 2021 - Online webinar

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

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

27 Jan 2021 - Online webinar

90 minute live webinar
14:00 (UK/London Time Zone)

The FDA Drug Approval Process

11-12 Mar 2021 - Online webinar
Also on: 20 Sep 2021

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

The Medical Device Summer School - From Concept to CE Marking

5-9 Jul 2021 - London

*A practical five-day course with interactive workshops - now in its 17th successful year!*

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

The New EU Animal Health Legislation for Veterinary Medicinal Products

5-6 May 2021 - Online webinar
Also on: 2 Nov 2021

The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

*INCLUDES: Interactive discussion sessions*

Variations to Marketing Authorisations

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

Veterinary Pharmaceutical Submissions in the EU

3-4 Mar 2021 - Online webinar
Also on: 6 Dec 2021

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.

Working Through Veterinary Drug Development in the EU and USA

7-10 Jun 2021 - London

This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.