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Biotech
GMP
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Medical Devices
Pharmaceutical
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Speaking Opportunities

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

Pharmaceutical

We are also running a series of Pharmaceutical events in Dubai in October click here for further information

36 courses in this category:

26 Jan 2016

A Practical Guide to Producing and Maintaining the PSMF

The new Pharmacovigilance Legislation of 2012 now requires companies to provide a PSMF and that this document should be ‘Inspections ready’. If this is not done correctly this can result in critical findgins for the Company that could set back further product launches or event sanctions against the Company existing products. Maintenance of the PSMF also is an important aspet for maintaining the Company compliance and these are reviewed in Regulatory Inspections. Can you afford not to get it right?

Full details

25 Jan 2016

A Practical Guide to Writing Risk Management Plans (RMPS)

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

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

21-23 Sep 2015
EUR 2380.00
GBP 1700.00
USD 2652.00

Also held on:
14 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

24 Sep 2015
EUR 826.00
GBP 590.00
USD 920.00

Also held on:
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

25 Sep 2015
EUR 826.00
GBP 590.00
USD 920.00

Also held on:
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

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

14-15 Dec 2015
EUR 1610.00
GBP 1150.00
USD 1794.00

Also held on:
14 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

18-20 Nov 2015
EUR 2175.00
GBP 1699.00
USD 2701.00

Also held on:
8 Jun 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

Full details

Dry Powder Inhalers: Annual Conference

Dry Powder Inhalers, Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI market,

Full details

27 Jan 2016

DSURS and PBRERS

This meeting will provide a comprehensive review of the expections and reporting requirements of both DSURs and PBRERs. Practical aspect of preparation will be dicussed together with the links to Risk Management Plans, Safety Reviews and other documents, to ensure you are up to date with some of the potential issues and challgenes in producing these important documents.

Full details

EU Pharmaceutical Regulations

This course will provide you with an up-tp-date overview of the European pharmaceutical regulatory environment, procedures and obligations. You will learn about the legal basis of regulation, how the registration procedures work, the format fo presentation of data and the importance of pre-submission actions and post authorisation obligations. There will be discussion on US differences.

Full details

10 Dec 2015
EUR 805.00
GBP 575.00
USD 897.00

Also held on:
30 Jun 2016

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

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

11 Dec 2015
EUR 805.00
GBP 575.00
USD 897.00

Also held on:
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

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

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

Pharmaceutical Registration Strategies in Europe & the US for Generics & Super Generics

This course has been specifically designed to address the training needs of those who are or will be involved in the preparation of development plans and/or registration dossiers for generics.

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

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

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

Pharmaceutical Regulatory Affairs in the Middle East

Pharmaceutical Regulatory Affairs in the Middle East

This seminar will provide you with an essential overview of the key areas of pharmaceutical regulatory affairs in the Middle East. This two day course will focus on practical aspects to assist with regulatory affairs in the region. The course will include interactive discussion sessions to allow you to exchange experiences with other delegates.

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

7-9 Dec 2015
EUR 2471.00
GBP 1765.00
USD 2753.00

Also held on:
20 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.

Full details

Pharmacovigilance for Support Staff

An introductory course aimed at Administrators, Secretaries, Personal Assistants and Support Staff working in the Pharmaceutical industry. Good drug safety and pharmacovigilance practice are vital for the successful development, marketing and defence of pharmaceutical products. This Management Forum seminar aims to provide an overview of the pharmacovigilance process for support staff who work directly or indirectly in this area. This invaluable course will provide an overview of the processes involved, discuss the roles and responsibilities involved as well as explaining key terminology.

Full details

8-9 Feb 2016
EUR 1806.00
GBP 1290.00
USD 2012.00

Also held on:
3 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

Full details

1-2 Dec 2015
EUR 1794.00
GBP 1150.00
USD 1794.00

Also held on:
4 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.

Full details

24-25 Sep 2015
EUR 1645.00
GBP 1175.00
USD 1833.00

Also held on:
3 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

Signal Detection and Regulatory Expectations

This course will provide an overview of all aspects of safety reviews and signal detection within a company and will cover signal evaulation for both innovator and generic products

Full details

2-3 Dec 2015
EUR 1806.00
GBP 1290.00
USD 2012.00

Also held on:
6 Jul 2016

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

20-22 Oct 2015
EUR 2310.00
GBP 1650.00
USD 2574.00

Also held on:
5 Apr 2016

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

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

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

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

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