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Mon, Nov 16, 2009		SCIENTIFIC ADVICE - Optimising Regulatory Input Into Drug Development - Seminar (The Rembrandt Hotel, London) Obtaining the right scientific advice at the right time can make or break a drug development programme, and companies are willing to invest considerable time & resources in managing scientific advice procedures. It is now seen as being essential rather than optional to obtain input from the regulatory authorities at key stages of development. This seminar will examine the routes available for obtaining scientific advice in Europe, provide insight as to how to manage these procedures effectively and discuss how to incorporate scientific advice into development programmes. Additionally an overview of the new NICE Scientific Advice Consultancy Service will be provided.
Mon, Nov 16, 2009		GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Lands End, Mumbai, India) The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
Mon, Nov 16, 2009		SCIENTIFIC ADVICE - Optimising Regulatory Input Into Drug Development - Course / Training / Workshop (Hotel to be advised, London) This seminar will examine the routes available for obtaining scientific advice in Europe (including covering the recent changes to the CPMP and MHRA procedures), as well as in the US and Japan, and will explore the means of securing the best possible input and integrating advice from several different sources into a single global development programme.
Mon, Nov 16, 2009 9:00am		Generic Medicine: IP / Legal and Regulatory Issues - Seminar (TAJ Hotels) To be held in 3 Indian cities: Mumbai, Delhi and Hyderabad. The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business. Topics to be covered include:  Understand the European Generic marketplace  Patents and how they affect generics  Data Exclusivity  DCP and European Regulatory System  Key aspects of European legislation
Tue, Nov 17, 2009		SCIENTIFIC ADVICE - Optimising Regulatory Input Into Drug Development - Course / Training / Workshop (Hotel to be advised, London) This seminar will examine the routes available for obtaining scientific advice in Europe (including covering the recent changes to the CPMP and MHRA procedures), as well as in the US and Japan, and will explore the means of securing the best possible input and integrating advice from several different sources into a single global development programme.
Wed, Nov 18, 2009		GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Palace, New Delhi, India) The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
Wed, Nov 18, 2009 9:00am		Generic Medicine: IP / Legal and Regulatory Issues - Seminar (TAJ Hotels) To be held in 3 Indian cities: Mumbai, Delhi and Hyderabad. The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business. Topics to be covered include:  Understand the European Generic marketplace  Patents and how they affect generics  Data Exclusivity  DCP and European Regulatory System  Key aspects of European legislation
Thu, Nov 19, 2009		European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne) This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Fri, Nov 20, 2009		European Regulatory Affairs - Course / Training / Workshop (SAS Radisson Hotel Boulogne) This training course will provide an excellent introduction to the European Regulatory Procedures for personnel in regulatory affairs, clinical research, project management and other disciplines involved in the development of medicinal products. The course will cover the evolution of the Registration Systems available for approval of products since January 1995 in the European Union, together with major changes in New Medicines Legislation. Title IV of Regulation EC726/2004 on the European Medicines Agency -Responsibilities and Administrative Structure, came into effect on May 20, 2004. The remainder of the Regulation and all of Directive 2004/27/EC became effective in November 20, 2005. The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail. Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure. Other issues that impact on successful regulatory strategy in Europe, Harmonisation of Summary of Product Characteristics, Article 30 and Article 31 referrals and Supplementary Protection Certificate for Patents will be described. Also reviewed and discussed is the legal status of medicinal products and the procedure for switching from prescription only sale to OTC sale, legislation controlling Medical Devices and the Clinical Trial Directive. The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in Regulatory Affairs. Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Fri, Nov 20, 2009		GENERIC MEDICINES/IP LEGAL & REGULATORY ISSUES - to be held in India - Course / Training / Workshop (Taj Krishna, Hyderabad, India) The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business.
Fri, Nov 20, 2009 9:00am		Generic Medicine: IP / Legal and Regulatory Issues - Seminar (TAJ Hotels) To be held in 3 Indian cities: Mumbai, Delhi and Hyderabad. The aim of this seminar is to shed some light on the legal background to the European generic industry and to provide an understanding of how it affects all parts of the business. Topics to be covered include:  Understand the European Generic marketplace  Patents and how they affect generics  Data Exclusivity  DCP and European Regulatory System  Key aspects of European legislation
Mon, Nov 23, 2009		Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal) This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Mon, Nov 23, 2009		BIOLOGICAL EVALUATION OF MEDICAL DEVICES - Understand The New Approach To Biological Evaluation And Its Practical Application - Conference (Harrington Hall Hotel, London) The ISO 10993 series of standards, covering biological evaluation of medical devices, are well established and regulatory authorities worldwide expect compliance. In Europe compliance with the EN ISO 10993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive. Several new parts in the series have been developed which promote a new philosophy of biological evaluation particularly parts 1, 2, 17 and 18. In addition, a major revision of ISO 10993-1 is near completion (FDIS) which incorporates a risk management approach and better co-ordinate the full set of the existing 20 parts in the series. This interactive seminar will provide practical opportunities for the application of these standards and the new approach to biological evaluation.
Tue, Nov 24, 2009		Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal) This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Tue, Nov 24, 2009		SUPPLIER QUALITY MANAGEMENT - How well do you know your Suppliers and Supply Chain? - Course / Training / Workshop (The Rembrandt Hotel, London) Topics to be Covered: Cost Effectiveness: The current trend is to source raw materials and APIs from outside Europe and the US, Supplies are more often sourced from India and China. Significant Challenges: Identification, Assessment, Approval, Management of the Supply Chain. The Regulatory Authorities: Close attention to how you manage your Supply Chain. The Impact on your Company: The impact of the increased attention from the Regulatory Authorities is felt both on large Pharma companies and smaller Generic manufacturers where the number of product lines present a daunting task if the supply chain is to be effectively managed
Tue, Nov 24, 2009		BIOLOGICAL EVALUATION OF MEDICAL DEVICES - Understand The New Approach To Biological Evaluation And Its Practical Application - Conference (Harrington Hall Hotel, London) The ISO 10993 series of standards, covering biological evaluation of medical devices, are well established and regulatory authorities worldwide expect compliance. In Europe compliance with the EN ISO 10993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive. Several new parts in the series have been developed which promote a new philosophy of biological evaluation particularly parts 1, 2, 17 and 18. In addition, a major revision of ISO 10993-1 is near completion (FDIS) which incorporates a risk management approach and better co-ordinate the full set of the existing 20 parts in the series. This interactive seminar will provide practical opportunities for the application of these standards and the new approach to biological evaluation.
Wed, Nov 25, 2009		Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal) This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Thu, Nov 26, 2009		Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal) This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Fri, Nov 27, 2009		Non-Clinical Safety Sciences and Their Regulatory Aspects - Course / Training / Workshop (Lisbon, Portugal) This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.
Fri, Dec 4, 2009		THE EU COSMETICS DIRECTIVE AND THE NEW COSMETICS REGULATIONS - Course / Training / Workshop (The Rembrandt Hotel, London) A quick examination of the cosmetic products sold in many European shops will pick up a significant number of products that do not comply with the EU Cosmetic Regulations. This demonstrates that there are many companies who do not understand the requirements. The EU has recently stated that they wish to enforce labelling requirements more vigorously and there are heavy fines for infringements. It is easy for the authorities to walk round any shop selling cosmetics and look at the labels. Even a minor infringement could lead to a time consuming investigation. Although very complex and lengthy, the regulations are actually quite straightforward if they are summarised, explained properly and put into context. The object of this seminar is to do just this in thorough but simple terms. You will learn what the EU Cosmetics Directive is, how to understand and comply with it.
Tue, Dec 8, 2009		ADVERSE EVENT MANAGEMENT DURING MEDICAL DEVICE CLINICAL STUDIES - Seminar (The Rembrandt Hotel, London, SW7) BENEFIITS IN ATTENDING: Understand the Significance of the Revision of the MDD In Relation to Adverse Incident Reporting Gain an Overview of the Current System In Europe Keep Abreast with GHTF Progress Know the Role of the Data Safety Monitoring Board Understand the Definitions and Classification of Adverse Events Get an Insight into Competent Authorities Expectations Learn What Happens After CE Marking COURSE OBJECTIVES At the end of the course delegates will be able to:- Explain the regulations governing the monitoring and reporting of adverse events Produce an appropriate adverse event form for use during a study Define and classify adverse events occurring during a study Understand the changes in the regulations and how they impact onadverse event reporting WHO SHOULD ATTEND Those responsible for monitoring medical device clinical studies and those involved in adverse event management and reporting in house and in the field, including; clinical and regulatory staff. Clinical Investigators and clinical site staff who conduct medical device clinical studies and would like to learn more about identifying, interpreting and reportingadverse events during the conduct of a device study. With: Janette Benaddi, Chief Executive Officer, Medvance Ltd.
Fri, Dec 11, 2009		RECURRING QUESTIONS IN BIOTECHNOLOGY AND CHEMISTRY CASE LAW OF THE EPO BOARDS OF APPEAL - AN OVERVIEW FOCUSED ON SOME RECENT DECISIONS AND CONTROVERSIAL POINTS - Course / Training / Workshop (The Rembrandt Hotel, London, SW7) This seminar will provide useful information on European case law in the fields of chemistry and biochemistry, by means of an up to date analysis of decisions of the European Patent Office Boards of Appeal, considering specifically the current topical issues and controversial points. Interaction between speakers and participants will be encouraged throughout the day.
Mon, Dec 14, 2009		PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London) Key topics to be addressed at this conference: Principles of Pharmacovigilance and Data Resources, Risk Management, Causality Assessment: Clinical Diagnosis of Adverse Events, Pharmacoepidemiological Studies, Practical Aspects of compiling PSURs, Pro-active Pharmacovigilance Pre- and Post Marketing, Monitoring and Reporting Adverse Reactions in Europe: Regulatory Framework, Clinical Trials, Post-Marketing, Risk/Benefit Analysis, Drug Surveillance in the USA & Japan, Prescription Event Monitoring and its Practical Use in England, Practical Pharmacovigilance Workshop, Approaches to organisation of safety surveillance in major pharmaceutical companies. This Management Forum 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 in pharmacovigilance in Europe, the USA, and Japan.
Tue, Dec 15, 2009		PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London) Key topics to be addressed at this conference: Principles of Pharmacovigilance and Data Resources, Risk Management, Causality Assessment: Clinical Diagnosis of Adverse Events, Pharmacoepidemiological Studies, Practical Aspects of compiling PSURs, Pro-active Pharmacovigilance Pre- and Post Marketing, Monitoring and Reporting Adverse Reactions in Europe: Regulatory Framework, Clinical Trials, Post-Marketing, Risk/Benefit Analysis, Drug Surveillance in the USA & Japan, Prescription Event Monitoring and its Practical Use in England, Practical Pharmacovigilance Workshop, Approaches to organisation of safety surveillance in major pharmaceutical companies. This Management Forum 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 in pharmacovigilance in Europe, the USA, and Japan.
Wed, Dec 16, 2009		PHARMACOVIGILANCE - Course / Training / Workshop (The Rembrandt Hotel, London) Key topics to be addressed at this conference: Principles of Pharmacovigilance and Data Resources, Risk Management, Causality Assessment: Clinical Diagnosis of Adverse Events, Pharmacoepidemiological Studies, Practical Aspects of compiling PSURs, Pro-active Pharmacovigilance Pre- and Post Marketing, Monitoring and Reporting Adverse Reactions in Europe: Regulatory Framework, Clinical Trials, Post-Marketing, Risk/Benefit Analysis, Drug Surveillance in the USA & Japan, Prescription Event Monitoring and its Practical Use in England, Practical Pharmacovigilance Workshop, Approaches to organisation of safety surveillance in major pharmaceutical companies. This Management Forum 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 in pharmacovigilance in Europe, the USA, and Japan.
Wed, Jan 20, 2010		EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE - Course / Training / Workshop (The Cavendish Hotel, London) WHO SHOULD ATTEND This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community. PREPARATION It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference. Chairman: Roland Gérard - Vice President Governmental Affairs and RegulatoryCompliance - Europe, Middle East, Africa and Canada - St Jude Medical With a Panel of Key European Experts, including representatives from Competent Authorities, Notified Bodies and Industry BENEFITS IN ATTENDING: ■ Understand the EU Vigilance Process ■ Realise the Legal Obligations ■ Know How to Handle Field Safety Corrective Actions (FSCAs) ■ Discover What a Notified Body Expects from an Audit on PMS Systems ■ Discuss Risk Management ■ Hear How Various Member States Handle Vigilance Reports ■ Clarify the Role of Notified Bodies in Vigilance and FSCAs ■ Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies
Thu, Jan 21, 2010		EC MEDICAL DEVICES VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE - Course / Training / Workshop (The Cavendish Hotel, London) WHO SHOULD ATTEND This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community. PREPARATION It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference. Chairman: Roland Gérard - Vice President Governmental Affairs and RegulatoryCompliance - Europe, Middle East, Africa and Canada - St Jude Medical With a Panel of Key European Experts, including representatives from Competent Authorities, Notified Bodies and Industry BENEFITS IN ATTENDING: ■ Understand the EU Vigilance Process ■ Realise the Legal Obligations ■ Know How to Handle Field Safety Corrective Actions (FSCAs) ■ Discover What a Notified Body Expects from an Audit on PMS Systems ■ Discuss Risk Management ■ Hear How Various Member States Handle Vigilance Reports ■ Clarify the Role of Notified Bodies in Vigilance and FSCAs ■ Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies
Thu, Jan 28, 2010		MEDICAL DEVICE CLINICAL STUDIES - Understand How to Conduct Pre and Post Market - Course / Training / Workshop (The Rembrandt Hotel, London) Benefits in attending: ■ Understand the affect of regulatory requirements on medical device clinical studies ■ Clarify what is involved in a Clinical Evaluation (Literature Review) ■ Discover how to design pre market and post market studies ■ Know what documentation is needed and what should go in a study master file ■ Discover how to obtain Research Ethics approval in each European Country ■ Plan how to prepare regulatory notifications to the Competent Authorities ■ Understand the key aspects of pre and post market study setup, management, monitoring and close down ■ Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study ■ Discuss how to prepare a paper or presentation for publication and marketing
Fri, Jan 29, 2010		MEDICAL DEVICE CLINICAL STUDIES - Understand How to Conduct Pre and Post Market - Course / Training / Workshop (The Rembrandt Hotel, London) Benefits in attending: ■ Understand the affect of regulatory requirements on medical device clinical studies ■ Clarify what is involved in a Clinical Evaluation (Literature Review) ■ Discover how to design pre market and post market studies ■ Know what documentation is needed and what should go in a study master file ■ Discover how to obtain Research Ethics approval in each European Country ■ Plan how to prepare regulatory notifications to the Competent Authorities ■ Understand the key aspects of pre and post market study setup, management, monitoring and close down ■ Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study ■ Discuss how to prepare a paper or presentation for publication and marketing
Mon, Mar 8, 2010 7:30pm		BIO-Europe Spring 2010 - Conference (CCIB (www.ccib.es) Barcelona, Spain)
Tue, Mar 9, 2010 7:30pm		BIO-Europe Spring 2010 - Conference (CCIB (www.ccib.es) Barcelona, Spain)
Wed, Mar 10, 2010 7:30pm		BIO-Europe Spring 2010 - Conference (CCIB (www.ccib.es) Barcelona, Spain)
Mon, Jun 7, 2010		Cardiovascular Clinical Trials in Emerging Markets 2010 - Conference (Prague, Czech Republic) The globalisation of clinical trials has meant that increasingly pharmaceutical and biotechnology companies are turning towards performing clinical trials in emerging markets such as Asia Pacific, Central and Eastern Europe, Latin America and the Middle east. Within these emerging markets, the ability to research new products can also provide a way to maximize its potential use in countries typically not considered for commercial viability. However cultural, ethical, logistical and regulatory challenges can prove to be the biggest roadblocks when conducting trials in emerging countries and this is particularly true when conducting cardiovascular clinical trials. The Congress will focus on the current results, problems and solutions of conducting cardiovascular clinical trials in key emerging markets as well as examining the challenges facing the pharmaceutical industry in pursuing a contemporary approach in the development of drugs and treatment in key areas.
Tue, Jun 8, 2010		Cardiovascular Clinical Trials in Emerging Markets 2010 - Conference (Prague, Czech Republic) The globalisation of clinical trials has meant that increasingly pharmaceutical and biotechnology companies are turning towards performing clinical trials in emerging markets such as Asia Pacific, Central and Eastern Europe, Latin America and the Middle east. Within these emerging markets, the ability to research new products can also provide a way to maximize its potential use in countries typically not considered for commercial viability. However cultural, ethical, logistical and regulatory challenges can prove to be the biggest roadblocks when conducting trials in emerging countries and this is particularly true when conducting cardiovascular clinical trials. The Congress will focus on the current results, problems and solutions of conducting cardiovascular clinical trials in key emerging markets as well as examining the challenges facing the pharmaceutical industry in pursuing a contemporary approach in the development of drugs and treatment in key areas.
Thu, Jul 1, 2010		EU PHARMACEUTICAL REGULATIONS ~ For the Pharmaceutical and Biotechnology Industries - An up-to-date Overview of Current EU Requirements - Course / Training / Workshop (Hotel to be Advised, London, UK) Regulatory Affairs has an acknowledged important role in the pharmaceutical industry, both in obtaining and maintaining marketing authorisations, therefore, knowledge of the current European requirements and the impact of legislative changes on the businesses are essential. This two-day seminar will: Explain how to obtain and maintain marketing authorisations, Provide an up-to-date overview of current EU regulatory requirements and procedures, Offer interactive presentations, Include two workshops designed to look at the practical implementation, Consolidate the information presented during the two days.
Fri, Jul 2, 2010		EU PHARMACEUTICAL REGULATIONS ~ For the Pharmaceutical and Biotechnology Industries - An up-to-date Overview of Current EU Requirements - Course / Training / Workshop (Hotel to be Advised, London, UK) Regulatory Affairs has an acknowledged important role in the pharmaceutical industry, both in obtaining and maintaining marketing authorisations, therefore, knowledge of the current European requirements and the impact of legislative changes on the businesses are essential. This two-day seminar will: Explain how to obtain and maintain marketing authorisations, Provide an up-to-date overview of current EU regulatory requirements and procedures, Offer interactive presentations, Include two workshops designed to look at the practical implementation, Consolidate the information presented during the two days.

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