VARIATIONS TO MARKETING AUTHORISATIONS in the EU 5 March 2015, Conf. No A3-1015 tion to Applicaister Reg Please PRINT your details: Title .................. First Name........................................... (Dr, Mr, Mrs, etc) Family name ................................................................... Position ........................................................................... Department..................................................................... Company ........................................................................ Company VAT No. .......................................................... Address .......................................................................... ........................................................................................ City ................................ Post Code .............................. Country............................................................................ Tel No. ............................................................................. Mobile No. ....................................................................... Fax No............................................................................. E-mail .............................................................................. ......................................................................................... Secretary’s Name ........................................................... VARIATIONS TO MARKETING AUTHORISATIONS IN THE EU Review of the Variations Regulations W Dates 5 March 2015 Start: 09.30 – Finish: 17.00 Registra tio Informati n on Registration & Coffee 5 March 2015 09.00 Venue and Accommodation The Rembrandt Hotel, 11 Thurloe Place, London SW7 2RS Hotel Tel: +44(0)20 7589 8100. Hotel Fax:+44(0)20 7225 3476. Email: [email protected] Subject to availability, a limited number of bedrooms have been reserved at the hotel at a special rate. Update on Mutual Recognition/Decentralised, Centralised and National Variations (with emphasis on UK and Ireland) Topics covered at this seminar: All bookings should be made directly with the hotel or online at www.sarova.com/rembrandt, quoting promo code ‘manforum’. Directions Opposite V&A Museum. Nearest underground station: South Kensington. www.sarova-rembrandthotel.com/location-local-attractions Fee £575 + VAT if applicable. The fee includes course documentation as well as mid-session refreshments and lunch. Invoice and confirmation will be forwarded to you. Register online at www.managementforum.co.uk or telephone +44 (0)1483 730071 Conference No. A3-1015 Payment by either: VISA MASTERCARD AMEX For Cancellation Policy and T&Cs see website ß NB: Cancellations must be received in writing by [email protected] Card No. ß Card Security No. www.management-forum.co.uk AMEX Expiry date........../......... Cheque enclosed payable to Management Forum Limited Purchase order number For Promotional Opportunities email: [email protected] [email protected] Tel: +44 (0) 1483 730071 ß Fax: +44 (0) 1483 730008 To Re gi JOIN US ON introduction to the EC system for Variations with An practical advice on the preparation and submission of Variation applications using the various European procedures n The Current Variations Regulations of the European Commission and procedures in practice n Review of latest requirements n Biologicals and Biotech n Pharmaceutical Variations n Clinical Variations n The Variations: how have they changed in practice (workshop) Chairman: Dr Patrick Salmon st er if you have NOT received confirmation seven days after registering please contact [email protected] Discounted Rates Available on application for personnel from non-profit making organisations and registered charities. Group discount available on request If you do not want to receive future mailings from Management Forum please contact [email protected] If you do not wish to receive selected third party mailings please contact [email protected] Senior Medical Officer, HPRA Speaker: Dr Anmar Marouf Senior Consultant Pharmaceutical Consultant, PAREXEL International, Germany 5 March 2015 The Rembrandt Hotel, London OBJECTIVE CHAIRMAN This meeting will give an introduction of the EC system for Variations with practical advice on the preparation and submission of Variation applications using the various European procedures. Dr Patrick Salmon is Senior Medical Officer, HPRA. He has worked for many years reviewing all types of application including national, mutual recognition, decentralised and centralised applications. He is one of the Irish CPMP delegates and Chairman of the ad hoc group on SmPC. He is the Irish alternate CHMP member and Chair of the SmPC group on harmonisation. There will be a review of experience with the latest Variation Regulations and of the available guidance on how they are being implemented. WHO SHOULD ATTEND The meeting is addressed to clinical and pharmaceutical personnel in the registration and regulatory affairs departments of the pharmaceutical industry, and all those involved in regulatory strategy for submissions to European markets. ATTENDANCE LIMITED TO 30 - EARLY REGISTRATION RECOMMENDED This limitation, a unique feature of all MANAGEMENT FORUM seminars, will give participants the opportunity for a thorough discussion of the complex issues to be covered by the programme. FORTHCOMING EVENTS For a full list of forthcoming conferences and seminars please visit our website at: www.management-forum.co.uk You may make a registration and request a brochure on-line. He previously worked as Medical Director in a CRO and then in the Irish office of a large international pharmaceutical company. SPEAKER Dr Anmar Marouf has over 10 years of hands-on experience in the pharmaceutical industry and CMC/Quality consulting and writing. As project lead and subject matter expert, he is currently coordinating and supervising various CMC/Quality related projects primarily within European centralised and decentralised procedures. He is an expert in the preparation, review and gap analysis of CMC/Quality documentation (CTD Modules 3 and 2.3, IMPDs), expert’s reports and applicant’s response documents. 09.30uThe Current Variations Regulations of the European Commission and procedures in Practice • Types of Variation • How to submit a Variation • Procedural and Practical Guidance • Processing timescales Dr Patrick Salmon 11.00uCoffee 11.15uThe Variations Regulations: the guidance • Examples of current experience • Common reasons for invalid applications Dr Anmar Marouf 12.30uLunch 13.45uVariations Workshop (Classification and Grouping) 15.15uTea 15.30uClinical Variations His experience in the pharmaceutical industry includes the manufacturing, packaging, technology transfer, validation, qualification and SOPs/documentation for pharmaceutical products of major pharmaceutical companies. • New indications • Extension of products into new patient groups • Supporting data and Expert Reports, including requirements for generic products • Amendments to safety information Dr Patrick Salmon Dr. Marouf holds a PhD in Pharmaceutical Technology from the University of Freiburg, Germany. 16.15uPharmaceutical Variations (chemicals, biologicals and biotech) DOCUMENTATION Participants will receive a course material folder containing comprehensive documentation provided by the speakers, which will be a valuable source of reference for the future. Programme A Certificate of Attendance for Professional Development will be given to each participant who completes the course • Variations involving the submission of European Pharmacopoeia Certificates of Suitability • Type II Variations versus Line Extensions • Drug Master Files • Quality Overall Summaries (Expert Reports) Dr Anmar Marouf 17.00uEnd of meeting
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