Offers

From time-to-time Management Forum have special offers for new clients and past delegates. From early registration, multiple bookings and many other discounts there is a saving to suit your budget.

Early registration offers available now

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

£699 £599
€979 €839
$1,090 $934

when booked before 20 Dec

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the 2017 update.

£699 £599
€979 €839
$1,090 $934

when booked before 20 Dec

This conference provides a unique opportunity to meet Competent Authorities, Notified Bodies, Lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to Post Marketing Surveillance including Vigilance

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 20 Dec

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.

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 20 Dec

A two-day course for those looking to improve their decision-making and problem-solving skills within the pharma industry. Also suitable for the biotech, medical device and animal health industries.

Fully updated programme!

£1,199 £999
€1,679 €1,399
$1,870 $1,558

when booked before 10 Jan

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

£699 £599
€979 €839
$1,090 $934

when booked before 20 Dec

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 20 Dec

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 17 Jan

A practical interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements

£1,299 £1,099
€1,819 €1,539
$2,026 $1,714

when booked before 15 Jan

A new comprehensive and practical two day seminar covering Patentability and State-of-the-art Searching

£1,299 £1,099
€1,819 €1,539
$2,026 $1,714

when booked before 15 Jan

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 17 Jan

This seminar will provide an essential overview of the key areas of requirements for approvals for Medical Devices in Latin America. Countries to be covered: Brazil, Mexico, Colombia and Peru

£699 £599
€979 €839
$1,090 $934

when booked before 17 Jan

Understand the importance of accuracy and attention to detail in day-to-day work

£599 £499
€839 €699
$934 $778

when booked before 24 Jan

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 17 Jan

Understanding the background, defining terms and objectives; fundamentals of FTO search scope, methods for searching for claimed features, using basic legal status tools to assist valuation, and understanding and reporting the results from an FTO perspective.

£699 £599
€979 €839
$1,090 $934

when booked before 15 Jan

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 17 Jan

A two-day no-nonsense plain English practical course to get-to-grips with business and contract law for busy business executives.

£999 £799
€1,399 €1,119
$1,558 $1,246

when booked before 15 Jan

Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 17 Jan

In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit

£699 £599
€979 €839
$1,090 $934

when booked before 15 Jan

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.

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 17 Jan

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English Law

£1,299 £1,099
€1,819 €1,539
$2,026 $1,714

when booked before 15 Jan

Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This course will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

£699 £599
€979 €839
$1,090 $934

when booked before 17 Jan

Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day

£699 £599
€979 €839
$1,090 $934

when booked before 15 Jan

An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and ‘mixed’ inventions with both patentable and non-patentable subject matter

£699 £599
€979 €839
$1,090 $934

when booked before 15 Jan

This seminar will provide essential guidance on how to undertake a successful conformity assessment process and subsequently apply (or continue to apply) the CE mark

PLEASE NOTE THE ORIGINAL DATE FOR THIS EVENT HAS CHANGED TO 8-9 MAY 2019

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 24 Jan

A step by step practical guide to Strategic IP Planning

Strategic IP Planning

10-12 Mar 2020

£1,799 £1,499
€2,519 €2,099
$2,806 $2,338

when booked before 15 Jan

This meeting 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.

£1,399 £1,199
€1,959 €1,679
$2,182 $1,870

when booked before 14 Feb

Two practical days to understand current best practice and generate creative,
value-added solutions to your management challenges

£1,299 £1,099
€1,819 €1,539
$2,026 $1,714

when booked before 12 Feb

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 17 Jan

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.

£699 £599
€979 €839
$1,090 $934

when booked before 14 Feb

This course provides an essential overview and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 17 Jan

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

£699 £599
€979 €839
$1,090 $934

when booked before 14 Feb

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

£1,299 £1,099
€1,819 €1,539
$2,026 $1,714

when booked before 12 Feb

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

Injectable Drug Delivery

18-19 Mar 2020

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 24 Jan

The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.

£1,399 £1,099
€1,959 €1,539
$2,182 $1,714

when booked before 12 Feb

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.

£1,299 £1,099
€1,819 €1,539
$2,026 $1,714

when booked before 14 Feb

This specialist five-day seminar running in Dubai has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

£2,599 £2,099
€3,639 €2,939
$4,054 $3,274

when booked before 11 Feb

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 14 Feb

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 14 Feb

Learn how to navigate competition law and ensure compliance while maximising opportunities for your business

£699 £599
€979 €839
$1,090 $934

when booked before 12 Feb

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

£1,399 £1,199
€1,959 €1,679
$2,182 $1,870

when booked before 14 Feb

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.

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 24 Jan

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

£1,849 £1,549
€2,589 €2,169
$2,884 $2,416

when booked before 14 Feb

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 24 Jan

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

£699 £599
€979 €839
$1,090 $934

when booked before 14 Feb

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 28 Feb

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)

£699 £599
€979 €839
$1,090 $934

when booked before 28 Feb

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.

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 24 Jan

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

NEW EVENT!

Biosimilars

31 Mar-1 Apr 2020

£1,499 £1,299
$2,099 $1,787
€2,338 €2,058

when booked before 28 Feb

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

£1,199 £999
€1,679 €1,399
$1,870 $1,558

when booked before 28 Feb

Practical Guidance on Borderline Issues and Combination Products

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 24 Jan

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.

£1,499 £1,299
$2,099 $1,787
€2,338 €2,058

when booked before 28 Feb

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

£699 £599
€979 €839
$1,090 $934

when booked before 28 Feb

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

£1,849 £1,549
€2,589 €2,169
$2,884 $2,416

when booked before 28 Feb

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 28 Feb

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

New for 2019

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 13 Mar

An Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management

£1,849 £1,549
€2,589 €2,169
$2,884 $2,416

when booked before 20 Mar

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.

£1,399 £1,199
€1,959 €1,679
$2,182 $1,870

when booked before 14 Feb

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.

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 20 Mar

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.

£1,399 £1,199
€1,959 €1,679
$2,182 $1,870

when booked before 10 Apr

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 20 Mar

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

An updated brochure will be available shortly!

£1,399 £1,199
€1,959 €1,679
$2,182 $1,870

when booked before 10 Apr

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

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 20 Mar

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.

£1,849 £1,549
€2,589 €2,169
$2,884 $2,416

when booked before 20 Mar

This conference gives a comprehensive review within the field of nasal drug delivery while reviewing the very latest new data and innovative technologies.

Nasal Drug Delivery

14-15 May 2020

£1,499 £1,299
€2,099 €1,819
$2,338 $2,026

when booked before 3 Apr