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Pharmaceutical

54 courses in this category:

5 Jul 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

4 Jul 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

8 Mar 2016
EUR 908.60
GBP 649.00
USD 1012.44

Also held on:
4 Oct 2016

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

14-16 Mar 2016
EUR 2518.60
GBP 1799.00
USD 2806.44

Also held on:
28 Sep 2016

Advanced Pharmacovigilance

This course will be of maximum benefit to those safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing

Full details

4 Oct 2016
EUR 908.60
GBP 649.00
USD 1012.44

An Essential Overview of Medical Information

An Essential Overview of Medical Information, understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring

Full details

18 Feb 2016
EUR 908.60
GBP 649.00
USD 1012.44

Also held on:
3 Oct 2016

An Essential Overview of Pharmacovigilance

Pharmacovigilance has become one of the most demanding aspects to both understand and comply with. There are many requirements for companies to perform regarding the safety of their products to satisfy regulatory demands, and sanctions for non compliance can be severe. This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements.

Full details

12 May 2016
EUR 908.60
GBP 649.00
USD 1012.44

Also held on:
11 Nov 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

13 May 2016
EUR 908.60
GBP 649.00
USD 1012.44

Also held on:
10 Nov 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

17 May 2016
EUR 838.60
GBP 599.00
USD 934.44

Also held on:
1 Dec 2016

Assertiveness for Maximum Impact

This course explores what is meant by ‘assertive behaviour’. It will provide you with an opportunity to practice skills and techniques to help you to become more assertive and more efficient in your dealings with clients and colleagues.

Full details

1-2 Mar 2016
EUR 1888.60
GBP 1349.00
USD 2104.44

Basic Principles of Pharmacokinetics

An introduction and overview of the main principles and concepts of Pharmacokinetics relating to drug discovery and development.

Full details

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

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

Full details

9-10 Jun 2016
EUR 1888.60
GBP 1349.00
USD 2104.44

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 Jun 2016
EUR 1888.60
GBP 1349.00
USD 2023.50

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

18-19 Apr 2016
EUR 1678.60
GBP 1199.00
USD 1870.44

Developing Effective Training Skills in the Pharma Industry

Developing Effective Training Techniques in the Pharma Industry, an interactive course ideal for anyone with responsibility for planning or delivering training in the Pharma, Device or Animal Health Industries (including GXP and SOP training to comply with EU and FDA inspection requirements). Relevant for both those who present training sessions as part of their role.

Full details

19 May 2016
EUR 909.00
GBP 649.00
USD 1012.00

Also held on:
22 Nov 2016

Drafting and Managing Pharmaceutical Safety Exchange Agreements

Some of the topics to be covered at this meeting include overview of the legal/policy landscape as it affects the terms of CTAs, clause by clause review, legal clauses, review of a Universitys CTA

Full details

8-10 Jun 2016
EUR 2379.00
GBP 1699.00
USD 2650.00

Also held on:
23 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

Full details

21-22 Apr 2016
EUR 1888.60
GBP 1349.00
USD 2104.44

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

6 Jul 2016
EUR 901.60
GBP 649.00
USD 1012.44

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

Essential GCP ICH E6 R2 Update

This course will enable you to meet the new international GCP standard to enable the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.

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

6-7 Oct 2016
EUR 1888.60
GBP 1349.00
USD 2104.44

EU Pharmaceutical Regulations & Strategy

This course will provide an up-to-date overview of trhe European pharmaceutical regulatory environment, rocedures and obligations. It wil be of particular value as an introductory or refresher course for those involved in regulatory affairs or who interact with regulatory personnel to understand action time-lines and requests for information.

Full details

30 Jun 2016
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

How to Write SOPs, Dubai

An essential course on how to ensure 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

1 Jul 2016
EUR 908.60
GBP 649.00
USD 1012.44

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

8-9 Mar 2016
EUR 1958.60
GBP 1399.00
USD 2182.44

Injectable Drug Delivery

The essential conference for pharmaceutical and medical device professionals covering advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods – plus a regulatory update

Full details

23 Feb 2016
EUR 908.60
GBP 649.00
USD 1012.44

Also held on:
27 Sep 2016

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

Keeping up-to-date as a Qualified Person, refresher and intermediate 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

10-11 Mar 2016
EUR 1678.60
GBP 1199.00
USD 1870.44

Also held on:
7 Nov 2016

Leadership Skills for Pharmaceutical Professionals

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

Full details

17-18 Mar 2016
EUR 1888.60
GBP 1349.00
USD 2104.44

Also held on:
13 Oct 2016

Managing Vendor/CRO/CMO Oversight in the Pharma Industry

On this course you will 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. You will also cover the techniques for successfully managing CROs / vendors and the shared responsibilities required by the sponsor and the service provider. Managing CRO performance issues will also be discussed.

Full details

7-8 Apr 2016
EUR 1888.60
GBP 1349.00
USD 2104.44

Nasal Drug Delivery

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

Full details

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 requirements, 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

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

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

12-14 Apr 2016
EUR 2158.80
GBP 1799.00
USD 2806.44

Pharmaceutical Regulatory Affairs in Asia

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

Full details

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

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

23-24 May 2016
EUR 1888.60
GBP 1349.00
USD 2104.44

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. Interactive discussion sessions will allow you to exchange experiences with other delegates

Full details

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

20-22 Jun 2016
EUR 2519.00
GBP 1799.00
USD 2806.00

Also held on:
6 Dec 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

7 Mar 2016
EUR 908.60
GBP 649.00
USD 1012.44

Pre-Filled Syringes

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

Full details

3-4 Oct 2016
EUR 1888.60
GBP 1349.00
USD 2104.44

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

4-5 Jul 2016
EUR 1678.60
GBP 1199.00
USD 1870.44

Project Management for Pharma Professionals

This leading project management course has been designed specifically for the Bio/Pharma Industry and is also applicable to those in medical device and animal health industries. It will provide you with a thorough understanding of project management skills, including both technical and interpersonal skills

Full details

3-4 Mar 2016
EUR 1678.60
GBP 1199.00
USD 1870.44

Also held on:
22 Sep 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

9-10 Jun 2016
EUR 1888.60
GBP 1349.00
USD 2104.44

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

6-7 Jul 2016
EUR 1888.60
GBP 1349.00
USD 2104.44

Also held on:
6 Dec 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

16 May 2016
EUR 838.60
GBP 599.00
USD 934.44

Also held on:
30 Nov 2016

Stress and Time Management

One of the biggest reasons cited for an increase in stress-related illnesses are the increased demands on our time, particularly in the workplace. For many of us there is never enough time to cope with all the demands placed upon us. This one day course looks at both time and stress management and suggests strategies for helping to manage both.

Full details

5-7 Apr 2016
EUR 2518.60
GBP 1799.00
USD 2770.46

Also held on:
19 Oct 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

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

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

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

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

18-20 May 2016
EUR 2448.60
GBP 1749.00
USD 2728.44

Also held on:
28 Nov 2016

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

9 Mar 2016
EUR 908.60
GBP 649.00
USD 1012.44

Also held on:
5 Oct 2016

Variations to Marketing Authorisations in the EU

Variations to Marketing Authorisations in the EU, review of the Variations regulations. Update on Mutual Recognition/Decentralised, Centralised and National Variations (with emphasis on UK and Ireland).

Full details