Animal Health
Biotech
GMP
Intellectual Property
Legal
Management Skills
Medical Devices
Pharmaceutical
Support Staff

Sponsoring & Exhibiting

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Event Management

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Speaking Opportunities

Speaking opportunities are available on selected Management Forum events, please contact us for further information

83 events found:

September 2015

10-11 Sep 2015
EUR 1680.00
GBP 1200.00
USD 1872.00

The FDA Drug Approval Process

General introduction and important information on FDA Procedures requirements for marketing authorizations and recent developments affecting the drug approval process in the US

Full details

21-23 Sep 2015
EUR 2380.00
GBP 1700.00
USD 2652.00

Advanced Pharmacovigilance

KEY TOPICS TO BE COVERED:-
Due Diligence
Training for Drug Safety, reporting duties, audits and expectations, risk based inspections
The DDPS retirement and the New PV Master File in the EU
Compliance and Drug Safety
Product Safety Reviews, purpose and function (incorporating the new EU Signal Analysis requirements)
Developing Company Core Safety Information CIOMS lll

Full details

22 Sep 2015
EUR 837.00
GBP 598.00
USD 932.00

Patent Protection for Software-Related and Business-Related Inventions in Europe and the US

TOPICS TO BE COVERED AT THIS SEMINAR – Developments in Europe for computer-related inventions – Latest US strategies post-Bilski, post-Alice and under the USPTO’s most recent guidelines – Global drafting and prosecution tactics for these technologies – Workshop questions, answers and discussion of examples

Full details

23-25 Sep 2015
EUR 2450.00
GBP 1750.00
USD 2730.00

Biotechnology for the Non-Biotechnologist

Biotechnology for the Non Biotechnologist, ideal for non-Scientists and Scientists needing to understand the basic theory, principles, techniques, and potential of biotechnology

Full details

23-24 Sep 2015
EUR 1806.00
GBP 1290.00
USD 2012.00

Introduction to Veterinary Pharmacovigilance

An Introduction to Veterinary Pharmacovigilance, 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 pharmacoviglance. New entrants, support staff as well as experienced personnel who require a better understanding of veterinary drug safety will benefit from the practical guidance provided. Key terminology will be explained and roles and responsibilities will be clarified. There will beplenty of time for interaction, questions and answers to enable participants to get a good understanding of this complex subject.

Full details

24 Sep 2015
EUR 826.00
GBP 590.00
USD 920.00

An Essential Overview of the Medical Device Industry

The Pharmaceutical Industry is increasingly developing Device combination products and looking to use novel methods of drug delivery.to enhance the performance of medicine and as a part of life cycle management. .Medical Devices are also being employed to monitor compliance in clinical trials and post marketing as well as being being used to monitor patients in trials. 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.

Full details

24-25 Sep 2015
EUR 1365.00
GBP 975.00
USD 1521.00

Annual Conference for Senior Trade Mark & Design Administrators

Senior Trade Mark & Design Administrators, speakers from WIPO discussing the Madrid and Hague systems, from OHIM discussing the guidelines, also
presentation about differences between US and EU practice and what to do about them.

Full details

24-25 Sep 2015
EUR 1645.00
GBP 1175.00
USD 1833.00

Regulatory Affairs for Support Staff

Regulatory Affairs for support staff , 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 role. You will gain an overview of EU regulatory procedures required to register products in Europe and the regulatory activities that need to be complied with to keep products on the market. Pharmacovigilance and safety reporting will be covered as well as license variations and the commercial aspects of Pharmaceutical products. The course will provide a thorough grounding in the subject of Regulatory Affairs and enable you to perform in your role more effectively.

Full details

25 Sep 2015
EUR 826.00
GBP 590.00
USD 920.00

An Essential Overview of the Pharmaceutical Industry

This programme will give you an invaluable overview of the Pharmaceutical industry, from discovery of the molecule through development to marketing

Full details

28-29 Sep 2015
EUR 1540.00
GBP 1100.00
USD 1716.00

Communication Alchemy

This two day course will challenge your current thinking and behaviour in all areas of communicaiton. Through a host of practical exercises, tools and techniques you will explore the impact of your communication style in winning over people, situations and business. The tools and techniques you will learn will positively change the way you communicatte in every situation with power, passion and enhanced purpose.

Full details

29-30 Sep 2015
EUR 1806.00
GBP 1290.00
USD 2012.00

FDA Approval Process for Medical Devices

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States. Participants will gain an understanding of the underlying legal and regulatory requirements and the ‘general controls’ applicable to all devices, including device classification, establishment registration and device listing. With the underlying framework in mind, the approval and clearance processes for new and modified devices will be presented, includeing 510 (k), IDE PMA, HDA and De Novo applications.

Full details

October 2015

1-2 Oct 2015
EUR 1792.00
GBP 1280.00
USD 1996.00

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

Practical Guidance on Borderline Issues and Combination Products practical guidance on Borderline issues and combination products

Full details

5-6 Oct 2015
EUR 1785.00
GBP 1275.00
USD 1989.00

Pharmaceutical Regulatory Affairs in Africa

Pharmaceutical Regulatory Affairs in Africa including South Africa, Algeria, Botswana, Ethiopia, Ghana, Kenya, Lamawi, Morocco, Mozambique, Nigeria, Namibia, South Africa, Tunisia, Uganda, Zambia, Zimbabwe. THis meeting will be of particular interest to those who need to learn about successful marketing authorisation applications and regulatory compliance in English speaking Africa. It will be useful as both an introductory or a refresher course on recent developments.

Full details

6-7 Oct 2015
EUR 1785.00
GBP 1275.00
USD 1989.00

ISO 13485: Quality Management System for Medical Devices

ISO 13485 quality management system, delivering safe medical deivces. A comprehensive overview of ISO 13485, you will compare the requirements of ISO 13485 and ISO 9001, understand the role and responsibilities of quality management. Consider the relationship between ISO 13485 and ISO 14971, Application to Risk Management to Medical Devices

Full details

7-9 Oct 2015
EUR 2450.00
GBP 1750.00
USD 2730.00

The Pharma Mini MBA

The Pharma 3 day Mini MBA accelerated management programme is a distillation of the most valuable parts of an MBA, as applied to the Bio/Pharmaceutical industry. It will provide you with practical management tools to apply in the workplace, as well as giving a real taste of an MBA course with Pharma case studies from business schools.

Full details

12-13 Oct 2015
EUR 1818.60
GBP 1299.00
USD 1896.00

Pharmaceutical Packaging, Labelling and Artwork Origination

This meeting has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation, technology, innovation and artwork origination.

Full details

14-15 Oct 2015
EUR 1701.00
GBP 1215.00
USD 1895.00

Abridged Applications

Abridged Applications, The Regulator and the Industry view, an intensive course examing the current requirements and current problems for those with a basic knowledge of the application procedure.

Full details

18-19 Oct 2015
EUR 1785.00
GBP 1275.00
USD 1989.00

Pharmaceutical Regulatory Affairs in the Middle East, Dubai

How to write SOPs Dubai. SOPs play a crucial role in compliance with regulations. It is therefore essential that they are well written and easy to use by the end-users. If SOPs are not followed correctly, the validity of data generated is compromised, leading to inspection findings and non-compliance issues which could lead to delays in bringing a drug/device tgo market. This SOP course has been specifically designed to help you develop the skills to write and produce the content SOPs, review and implement SOPs to ensure you are able to comply in a regulated environment. You will come away with the confidence to use a process to write, update and implement SOPs which can easily be used by the end users.

Full details

19 Oct 2015
GBP 575.00
USD 897.00

How to Write SOPs, Dubai

How to Write Sops, An Essential Course of Ensuring Compliance with Regulatory Requirements. Topics to be covered include How to write concise and user friends SOPs, Understanding how to prepare the contents of SOPs. How to implement, manage and review SOPs effectively, how to ensure your SOPs incorporate appropriate regulatory requirements, plus how to design effective SOP training

Full details

20-21 Oct 2015
EUR 1806.00
GBP 1290.00
USD 2012.00

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

A Practical Approach to Veterinary Vaccine Development and Registration in the EU 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. The workshops willl assist delegates to gain a better understanding of the requirements in practice. There will be ample time for discussion during the two days.

Full details

20-22 Oct 2015
EUR 2310.00
GBP 1650.00
USD 2574.00

Successful Medical Writing

Succesful Medical Writing. Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals. This process largely relies on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring success. This intensive practical medical writing course will benefit participants by enabling them to achieve this standard.

Full details

20-21 Oct 2015
EUR 1610.00
GBP 1150.00
USD 1794.00

Successful Pharma Project Management, Dubai

Successful Pharma Project Management, the leading project management course designed specificaly for the Bio/Pharma and Medical Device industries.

Full details

20-21 Oct 2015
EUR 1785.00
GBP 1275.00
USD 1989.00

The New Saudi Arabian Pharmacovigilance Guidelines of June 2015, Dubai

The new KSA pharmacovigilance guidelines were issued in May 2015 with their introduction on 27th June 2015. There are fundamental changes to Pharmacovigilance practice described in these guidelines which very much follow the EU guidelines, issued and implemented in June 2012. This intensive 2 day course will look at the various new topics and their practical application from the perspective of the introduction of the EU Guidelines. The course will include experiences of Inspections and audits following implementation and what the main focus points will be.

Full details

22 Oct 2015
EUR 833.00
GBP 595.00
USD 928.00

Registration of Veterinary Vaccines in the USA and Canada

Registration of Veterinary Vaccines in USA and Canada, understanding the licensing of veterinary vaccines by USDA and CFIA, understand the phased submission process for vaccine licesensing, learn the format and content specifications for the required dossier components, review the extensive and etaisl USDA regulations (9CFR) and guidance (memoranda, notices, supplemental information formats (SIF), supplemental assay methods (SAM). Compare the regulatory fee structures (no fees for USDA-licensing, minimal fees for Canadian licensing of biologics)

Full details

29-30 Oct 2015
EUR 1365.00
GBP 975.00
USD 1521.00

14th Annual Conference for Senior Patent Administrators

On the agenda this year: – European Patent Formalities Update – The Unified Patent and the Unified Patent Court – US Patent Formalities – PCT Update.

Full details

November 2015

2-3 Nov 2015
EUR 1806.00
GBP 1290.00
USD 2012.00

An Introduction to Medical Device Software: Regulations and Requirements

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

Full details

2 Nov 2015
EUR 837.00
GBP 598.00
USD 932.00

International Licensing, Manufacture Under Licence and Technology Transfer Agreements

International Licensing, Manufacture Under licence, and Technology Transfer Agreements ~ Understanding and Drafting, licensing agreements are frequently used by commercial entities and public or quasi public bodies, for the development of new business prospects and for cross-border expansion. This seminar will give practical advice on the legal and commercial considerations essential for securing a successful deal.

It offers a comprehensive overview of all the key matters to be considered – by the licensor and the licensee – when dealing with international licensing agreements generally and in particular when handling manufacture under licence and technology transfer agreements.

This seminar is not jurisdiction specific and is therefore ideal for those working both in the UK and overseas.

Full details

10-12 Nov 2015
EUR 2422.00
GBP 1730.00
USD 2698.00

An Introduction to the Medical Devices Directive

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do. It will also cover the documentation necessary to apply for the CE Mark.

This is an excellent introduction from leading experts in the field and delegates should expect three comprehensive days of training.

Full details

10-11 Nov 2015
EUR 1806.00
GBP 1290.00
USD 2012.00

Medical Device Studies: Clinical Evidence

This seminar has been designed specifically for those who are involved in gathering clinical evidence required for medical devices and in-vitro diagnostic products. Clinical data is required for all medical devices and the emphasis on high quality, appropriate clinical evidence has grown substantially in the last few years. Clinical evidence is key to bringing a device to market and is a very important aspect of post market evidence gathering to meet the legislatio. The collection of clinical data to demonstrate safety and performance of a device is pivotal to CE marking a medical device. The collection of post market data is a key aspect of continued safety and performance considerations once the device is on the market.

This course will cover the full range of activities that should be applied during the collection of clinical evidence for both pre and post market studies. It will provide delegates with information on the European regulations for gathering clincal evidence and conducting medical device studies and help them to run studies in Europe and other countries.

Full details

16-17 Nov 2015
EUR 1785.00
GBP 1275.00
USD 1989.00

New EU Pharmacovigilance Legislation

The 15 new EU modules concerning Pharmacovigilance are a major departure in terms of the way Pharmacovigilance is conducted in Europe. The intention of the course is to look at these modules and their requiremnts, examine how they overlap and fit together and what Companies need to do in terms of their legal requirements; training, changes and introduction of SOPs; and the links to other Departments – not just Pharmacovigilance but also including Clinical; Medical Information; Marketing; IT; Quality; Regulatory; Training and GMP

Full details

16-18 Nov 2015
EUR 2380.00
GBP 1700.00
USD 2652.00

Pharmaceutical Regulatory Affairs in Latin America

Pharmaceutical Regulatory Affairs in Latin America a comprehensive review of the evolving regulatory environment, emphasising the challenges and opportunities for the Pharma Industry in key Latin Americal countries

Full details

18-20 Nov 2015
EUR 2175.00
GBP 1699.00
USD 2701.00

Drafting Commercial Contracts for the Pharmaceutical Industry

A 3-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors

Full details

19-20 Nov 2015
EUR 1890.00
GBP 1350.00
USD 2106.00

Inhaled Drug Delivery

Inhaled Drug Delivery – this course will include case studies, regulatory updates, latest therapies and technology innovations

Full details

23-25 Nov 2015
EUR 2450.00
GBP 1750.00
USD 2730.00

Strategic IP Planning

Strategic IP Planning, topics covered at this seminar include step by step practical guide to Strategic IP Planning, utilising a structured and rationalised IP strategy toolboox, competitive IP Analysis and market positioning. IP SWOT, align IP with R&D and business goals, performance benchmarking, measures and KPIs. IP planning as part of your daily role, presenting your plan persuavisely.

Full details

24-25 Nov 2015
EUR 1785.00
GBP 1275.00
USD 1989.00

Clinical Trial Regulatory Guideline Requirements

Are you up to date with the regulatory requirements for clinical research in Europe? Do you understand the impact of the new EU Clinical Trials Regulation? The EU Clinical Trials Regulation was finalised and published by the Official Journal of the EU in May 2014 and is due to come into force in 2016. This new regulation will replace the European Clinical Trials Directive (2001/20/EC). This course will provide an essential understanding to help with compliance for clinical trials, particularly carried out in the EU

Full details

26 Nov 2015
EUR 837.00
GBP 598.00
USD 932.00

Change Management in IP

By attending this practical one day course, attendees will learn basic foundations on change management and how to apply them to your IP context, discover classic models of the change process applicable to the IP function – Review state-of-the-art tactics to support the change process, including tactics directly actionable by IP professionals, take away a practical toolkit with a structured, step-by-step methodology to implement change in your IP organization, design your own change plan by applying concepts and tools learned during the seminar, through a series of guided exercises and carry out self-diagnosis of your organization’s IP readiness, and benchmark it with average and best practices

Full details

26-27 Nov 2015
EUR 1785.00
GBP 1275.00
USD 1989.00

Pharmaceutical Regulatory Affairs in China

This seminar will provide a detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong Macau and Taiwan and will cover all important aspects of gaining and maintaining a successful Marketing Authorisation in the region, CMC regulatory requirements, interpretation of practical aspects and an overview of the requirements for local manufacturing

Full details

26-27 Nov 2015
EUR 1610.00
GBP 1150.00
USD 1794.00

The Art of European Claim Drafting

This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.

Full details

December 2015

1-2 Dec 2015
EUR 1393.00
GBP 995.00
USD 1552.00

Advanced PCT Formalities

Advanced PCT Formalities

Full details

1-2 Dec 2015
EUR 1794.00
GBP 1150.00
USD 1794.00

Project Management for Pharma Professionals

This leading Project Management course has been designed specifically for the Bio/Pharma Industry – also applicable to those in Medical Device and Animal Health Industries and will provide you with a thorough understanding of project management skills, including both technical and interpersonal skills.

Full details

2-3 Dec 2015
EUR 1806.00
GBP 1290.00
USD 2012.00

Stability Testing of Pharmaceuticals

Stability Testing of Pharmaceuticals. By attending this comprehensive two day seminar delegates will learn how to design efficient stability studies that are suitable for global marketing, be able to carry out apporpriate stability studies and manage stability samples and facilities. Also know how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols

Full details

3 Dec 2015
EUR 805.00
GBP 575.00
USD 897.00

The Borderline Between Medicines and Foods

Medicines treat, cure or prevent illness. Foods provide nutrition. But are the distinctions so clear?
Foods also have a physiological effect and a role in disease risk reduction – and substances whose purpose is nutritional may be presented as medicines. An understanding of where the borderline lies between medicines and foods is essential for the successful marketing of specialist health products: getting it wrong is a costly route to market failure.
However, the regulatory framework is detailed and complex, requiring a knowledge of the relevant legislation. By addressing these topics, this seminar aims to assist delegates to an understanding of how the borderline may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

Full details

3-4 Dec 2015
EUR 1610.00
GBP 1150.00
USD 1794.00

US Patent Practice

US Patent Practice, What European patent attorneys need to know. A 2-day highly interactive seminar

Full details

7-9 Dec 2015
EUR 2471.00
GBP 1765.00
USD 2753.00

Pharmacovigilance

This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments, pharmaceutical physicians and drug safety officiers. It will also be of direct benefit to all those who are involved and interested in the daily practice of pharmacovigilance.

Full details

7-8 Dec 2015
EUR 1806.00
GBP 1290.00
USD 2012.00

Veterinary Pharmaceutical Submissions in the EU

Veterinary Pharmaceutical Submissions in the EU. Chaired by Dr. Ray Harding, Consultant to the Animal Feed

Full details

9 Dec 2015
EUR 837.00
GBP 598.00
USD 932.00

The Impact of Patent Construction - How to Prove Infringement and Validity

This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany, a comparison and explanation of the varying approaches for determining when a patent claim that does not literally describe an accused system is nonetheless infringed. As well as exemplary fact scenarios with comparisons of the USA, UK and Germany approaches to claim construction and validity determination.

Full details

10-11 Dec 2015
EUR 1806.00
GBP 1290.00
USD 2012.00

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

Two day meeting on Regulation Update on Animal Feed and Feed Additives in the EU, USA and China, annual conference now in its 6th successful year.

Full details

10-11 Dec 2015
EUR 1610.00
GBP 1150.00
USD 1794.00

How to Avoid Common Pitfalls in Combined EU/US Patent Applications

How to Avoid Common Pitfalls in Combined EU/US Patent Applications. This seminar addresses the parallel, but substantially different, rules for drafting and prosecuting patents required by the Examiners and Appeal Boards of the EPO and USPTO.

Full details

10 Dec 2015
EUR 805.00
GBP 575.00
USD 897.00

How to Write SOPs

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

Full details

11 Dec 2015
EUR 805.00
GBP 575.00
USD 897.00

Improving Processes and CAPA (Corrective and Preventative Action)

This meeting 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

Full details

14-15 Dec 2015
EUR 1610.00
GBP 1150.00
USD 1794.00

Common Technical Dossier

This course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Furthermore, the course examines the requirements for Global roll out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories.

You will increase your ability to manage all aspects of development of the CMC aspects of applications after two days of intensive lectures, group work and discussion sessions, coverying everything you need to know about compiling the chemistry and pharmacy section of your generic dossier

Full details

January 2016

18-20 Jan 2016
EUR 2518.60
GBP 1799.00
USD 2806.44

28 Jan 2016

Personal Impact Using Emotional Intelligence

In today’s competitive workplace, it is becoming as important as technical skills to have strong people skills and understand the power of emotional intelligence. You must be able to communicate, influence and motivate to enhance internal andexternal relationships and to help improve both yours and the business performance. Being able to connect with people and win their trust is vital, but many people are left to acquire these skills through a process o ftrial and error.

This practical and interactive emotional intelligence traiing will increase your self-awareness and develop your interpersonal skills so you come across with positive impact, whatever the situation.

Full details

29 Jan 2016

Improving Performance Through Increased Accuracy and Attention to Detail

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

Full details

February 2016

8-9 Feb 2016
EUR 1806.00
GBP 1290.00
USD 2012.00

Process Validation in the US and EU

Process Validation in the US and Eu, balancing Science and risk during the Product Lifecycle. This 2 day meeting will help you 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

Full details

23 Feb 2016
EUR 833.00
GBP 595.00
USD 928.00

Keeping Up-To-Date as a (GMP) Qualified Person

Keeping up-to-date as a Qualified Person, Refresher and Intermedicate Training. A Continuing Professional Development (CPD) workshop for GMP QPs. Providing up-to-date and detailed guidance for current, trainee and returning QPs, to help you fulfil your duties effectively and efficiently in the Pharmaceutical Industry.

Full details

25 Feb 2016
GBP 598.00

Contract Law 2016

Contract Law 2016 – this is an ideal seminar for those wishing to increase their understanding of the fundamentals of contract law, and understand and improve the contracts they negotiate and manage

Full details

March 2016

3-4 Mar 2016

Regulatory Affairs for Support Staff

Regulatory Affairs for support staff , 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 role. You will gain an overview of EU regulatory procedures required to register products in Europe and the regulatory activities that need to be complied with to keep products on the market. Pharmacovigilance and safety reporting will be covered as well as license variations and the commercial aspects of Pharmaceutical products. The course will provide a thorough grounding in the subject of Regulatory Affairs and enable you to perform in your role more effectively.

Full details

7-8 Mar 2016

Communication Alchemy

This two day course will challenge your current thinking and behaviour in all areas of communicaiton. Through a host of practical exercises, tools and techniques you will explore the impact of your communication style in winning over people, situations and business. The tools and techniques you will learn will positively change the way you communicatte in every situation with power, passion and enhanced purpose.

Full details

14-16 Mar 2016

Advanced Pharmacovigilance

KEY TOPICS TO BE COVERED:-
Due Diligence
Training for Drug Safety, reporting duties, audits and expectations, risk based inspections
The DDPS retirement and the New PV Master File in the EU
Compliance and Drug Safety
Product Safety Reviews, purpose and function (incorporating the new EU Signal Analysis requirements)
Developing Company Core Safety Information CIOMS lll

Full details

April 2016

5-7 Apr 2016
EUR 2310.00
GBP 1650.00

Successful Medical Writing

Succesful Medical Writing. Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals. This process largely relies on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring success. This intensive practical medical writing course will benefit participants by enabling them to achieve this standard.

Full details

13-14 Apr 2016
EUR 1806.00
GBP 1290.00

Introduction to Veterinary Pharmacovigilance

An Introduction to Veterinary Pharmacovigilance, 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 pharmacoviglance. New entrants, support staff as well as experienced personnel who require a better understanding of veterinary drug safety will benefit from the practical guidance provided. Key terminology will be explained and roles and responsibilities will be clarified. There will beplenty of time for interaction, questions and answers to enable participants to get a good understanding of this complex subject.

Full details

27-29 Apr 2016
EUR 2450.00
GBP 1750.00

Biotechnology for the Non-Biotechnologist

Biotechnology for the Non Biotechnologist, ideal for non-Scientists and Scientists needing to understand the basic theory, principles, techniques, and potential of biotechnology

Full details

May 2016

10-12 May 2016
EUR 2450.00
GBP 1750.00
USD 2730.00

Strategic IP Planning

Strategic IP Planning, topics covered at this seminar include step by step practical guide to Strategic IP Planning, utilising a structured and rationalised IP strategy toolboox, competitive IP Analysis and market positioning. IP SWOT, align IP with R&D and business goals, performance benchmarking, measures and KPIs. IP planning as part of your daily role, presenting your plan persuavisely.

Full details

12 May 2016

An Essential Overview of the Medical Device Industry

The Pharmaceutical Industry is increasingly developing Device combination products and looking to use novel methods of drug delivery.to enhance the performance of medicine and as a part of life cycle management. .Medical Devices are also being employed to monitor compliance in clinical trials and post marketing as well as being being used to monitor patients in trials. 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.

Full details

12-13 May 2016
GBP 1150.00

The Art of European Claim Drafting

This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.

Full details

13 May 2016

An Essential Overview of the Pharmaceutical Industry

This programme will give you an invaluable overview of the Pharmaceutical industry, from discovery of the molecule through development to marketing

Full details

13 May 2016
GBP 0.00

Change Management in IP

By attending this practical one day course, attendees will learn basic foundations on change management and how to apply them to your IP context, discover classic models of the change process applicable to the IP function – Review state-of-the-art tactics to support the change process, including tactics directly actionable by IP professionals, take away a practical toolkit with a structured, step-by-step methodology to implement change in your IP organization, design your own change plan by applying concepts and tools learned during the seminar, through a series of guided exercises and carry out self-diagnosis of your organization’s IP readiness, and benchmark it with average and best practices

Full details

17 May 2016
GBP 0.00

International Licensing, Manufacture Under Licence and Technology Transfer Agreements

International Licensing, Manufacture Under licence, and Technology Transfer Agreements ~ Understanding and Drafting, licensing agreements are frequently used by commercial entities and public or quasi public bodies, for the development of new business prospects and for cross-border expansion. This seminar will give practical advice on the legal and commercial considerations essential for securing a successful deal.

It offers a comprehensive overview of all the key matters to be considered – by the licensor and the licensee – when dealing with international licensing agreements generally and in particular when handling manufacture under licence and technology transfer agreements.

This seminar is not jurisdiction specific and is therefore ideal for those working both in the UK and overseas.

Full details

June 2016

6-10 Jun 2016

Animal Health Summer School - Working Through Veterinary Drug Development in the EU and USA

A practical five day course Working through Veterinary Drug Development in the EU and the USA

Full details

8-10 Jun 2016
EUR 2175.00
GBP 1699.00
USD 2701.00

Drafting Commercial Contracts for the Pharmaceutical Industry

A 3-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors

Full details

14-15 Jun 2016

Common Technical Dossier

This course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Furthermore, the course examines the requirements for Global roll out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories.

You will increase your ability to manage all aspects of development of the CMC aspects of applications after two days of intensive lectures, group work and discussion sessions, coverying everything you need to know about compiling the chemistry and pharmacy section of your generic dossier

Full details

16-17 Jun 2016
GBP 0.00

US Patent Practice

US Patent Practice, What European patent attorneys need to know. A 2-day highly interactive seminar

Full details

20-22 Jun 2016

Pharmacovigilance

This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments, pharmaceutical physicians and drug safety officiers. It will also be of direct benefit to all those who are involved and interested in the daily practice of pharmacovigilance.

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22-23 Jun 2016

Connectivity in Medical Technology

Understanding connected medical devices, medical mobile Apps and the Medical Device Internet of Things

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30 Jun 2016
GBP 575.00

How to Write SOPs

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

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July 2016

1 Jul 2016

Improving Processes and CAPA (Corrective and Preventative Action)

This meeting 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

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4-5 Jul 2016

Project Management for Pharma Professionals

This leading Project Management course has been designed specifically for the Bio/Pharma Industry – also applicable to those in Medical Device and Animal Health Industries and will provide you with a thorough understanding of project management skills, including both technical and interpersonal skills.

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4-8 Jul 2016

The Medical Device Summer School - From Concept to CE Marking

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. It will commence with a general introduction as to what devices are and how they are developed, and continue with lectures, workshops and case studies covering each process appliatble to device development, marketing and eventually the post market procedures. There will be ample time for informal discussions alongide the presentations and workshops.

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6-7 Jul 2016
EUR 1806.00
GBP 1290.00

Stability Testing of Pharmaceuticals

Stability Testing of Pharmaceuticals. By attending this comprehensive two day seminar delegates will learn how to design efficient stability studies that are suitable for global marketing, be able to carry out apporpriate stability studies and manage stability samples and facilities. Also know how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols

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September 2016

27 Sep 2016
EUR 833.00
GBP 595.00

Keeping Up-To-Date as a (GMP) Qualified Person

Keeping up-to-date as a Qualified Person, Refresher and Intermedicate Training. A Continuing Professional Development (CPD) workshop for GMP QPs. Providing up-to-date and detailed guidance for current, trainee and returning QPs, to help you fulfil your duties effectively and efficiently in the Pharmaceutical Industry.

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October 2016

3-4 Oct 2016

Process Validation in the US and EU

Process Validation in the US and Eu, balancing Science and risk during the Product Lifecycle. This 2 day meeting will help you 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

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November 2016

23-25 Nov 2016

Drafting Commercial Contracts for the Pharmaceutical Industry

A 3-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors

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