ESSENTIAL PHARMACOVIGILANCE W 30 October 2014, Conf. No. A10-4514 tion to Applicaister Reg Please PRINT your details: Title .................. First Name........................................... Dates 30 October 2014 Start: 09.30 – Finish: 17.00 (Dr, Mr, Mrs, etc) Registration & Coffee Family name ................................................................... Venue Position ........................................................................... Department..................................................................... Company ........................................................................ Company VAT No. .......................................................... Address .......................................................................... ........................................................................................ City ................................ Post Code ............................. Country........................................................................... Tel No. ............................................................................. Fax No............................................................................. E-mail ............................................................................. Secretary’s Name ........................................................... Payment by either: VISA MASTERCARD AMEX Registra tio Informati n on ESSENTIAL PHARMACOVIGILANCE 30 October 2014 09.00 Raffles Dubai Hotel, UAE Sheikh Rashid Road Wafi - P O Box 121800 Dubai - UAE Accommodation Topics to be covered will include: All booking should be made directly to the hotel quoting this Management Forum meeting, together with your credit card details. n An Introduction to Pharmacovigilance n Documentation to be Supplied to Regulatory Authorities n Department Links in the Company to Pharmacovigilance n Licensing Partners and Pharmacovigilance n The Role of the Qualified Person for Pharmacovigilance n Standard Operating Procedures (SOPs) in Relation to Pharmacovigilance n Pharmacovigilance Inspections Raffles Dubai Hotel, Sheikh Rashid Road, Wafi, PO Box 121800, Dubai, UAE Hotel Tel: +971 4324 8888 Hotel Fax: +971 4324 6000 Website: www.dubai.raffles.com Fee £575. The fee includes course documentation as well as mid-session refreshments and lunch. Invoice and confirmation will be forwarded to you. Conference No. A10-4514 Card No. Card Security No. Discounted Rates Available on application for personnel from non-profit making organisations and registered charities. Group discount available on request AMEX Expiry date........../......... Cheque enclosed payable to Management Forum Limited Bank transfer on receipt of invoice ß l tia en s Es iew An verv O +44 (0) 1483 730008 Management Forum Ltd To Reg is ter www.management-forum.co.uk E-mail: registrations@management-forum.co.uk If you have NOT received confirmation seven days after registering, please contact Registration Department. Cancellation Policy: Over 14 days prior to the Seminar: Cancellation fee of £75. 7/14 days prior to the Seminar: 50% of the fee. Fewer than 7 days or if no notification received: Registrant liable to pay FULL seminar fee. NB: Cancellations must be received in writing by registrations@management-forum.co.uk Management Forum reserves the right to cancel/ alter the programme, the speakers, the date or venue. If an event is cancelled Management Forum is not responsible for airfare, hotel or other costs incurred by registered delegates. JOIN US ON With Graeme Ladds, Director, PharSafer Associates You can register online at www.management-forum.co.uk or by phone on +44 (0)1483 730071, fax 730008 For Promotional Opportunities email: robert@management-forum.co.uk If you do not want to receive future mailings from Management Forum please contact nick@management-forum.co.uk If you do not wish to receive selected third party mailings please contact nick@management-forum.co.uk MANAGEMENT FORUM LTD, 98-100 Maybury Road, Woking, Surrey GU21 5JL, UK Tel: +44 (0)1483 730071 Fax: +44 (0)1483 730008 Website: www.management-forum.co.uk 30 October 2014 Raffles Dubai Hotel, Dubai, UAE WHY SHOULD YOU ATTEND COURSE TUTOR Pharmacovigilance activities are becoming more global with new legislation being approved in many countries around the world. The requirement almost overnight to understand local and international requirements can put a strain on any Company. This course will provide an essential overview. This course has been specficially designed to to explain what Companies need to be aware of in terms of their responsibilities. Can you afford not to know? Graeme Ladds, Director of PharSafer, has over 20 year’s experience working in the Pharmaceutical Industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. The last ten years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe, Asia and the USA, SOP writing, safety database selections, acting as QP for companies, and helping with regulatory inspections. WHO SHOULD ATTEND This one day course is aimed at people within Pharmacovigilance, Regulatory, QA and Medical Information to help understand the fundamentals of the role of Pharmacovigilance, both in terms of the legislation and duties to be performed. It will also help to understand where Pharmacovigilance fits in the Company organisation and the Departments it serves. 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. Other Management Forum courses running in Dubai: Pharma Mini MBA 27, 28, 29 October 2014 Pharmaceutical Regulatory Affairs in the Middle East 28 & 29 October 2014 Please visit www.management-forum.co.uk for further information Programme u Introduction & Welcome u An Introduction to Pharmacovigilance u Documentation to be Supplied to Regulatory Authorities u Department Links in the Company to Pharmacovigilance u The Roles and Responsibilities of a Licence Holder u The Role of the Qualified Person (QP) for Pharmacovigilance DOCUMENTATION u Participants will receive a course material folder containing comprehensive documentation provided by the seminar leader, which will be a valuable source of reference for the future. Standard Operating Procedures (SOPs) in Relation to Pharmacovigilance u Pharmacovigilance Inspections u Close of Meeting u Discussion will take Place throughout the Day ATTENDANCE LIMITED – 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. To register please visit www.management-forum.co.uk, or for any further information contact Sarah Spanswick at sarah@management-forum.co.uk • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Safety reporting requirements Safety report sources Follow up of safety reports Electronic safety reporting Safety file retention Individual Case Safety Reports Periodic Safety Update Reports (PBRERs, DSURs, RMPs) Answering queries from Regulatory Authorities Updating product labelling – emphasis on safety changes Product Quality and Pharmacovigilance Sales and Marketing and Pharmacovigilance Legal, Commercial and Pharmacovigilance Regulatory and Pharmacovigilance Medical Information and Pharmacovigilance Obtaining a license for a product Supporting the license approval Submissions and license approvals Regulatory Inspections Contract versus permanent Essential attributes of the QP The duties of the QP What the QP must do Internal audits of the Company Pharmacovigilance activities Types of SOPs required Production and sign off of SOPs SOP maintenance SOP training Who should be trained in what Preparation for a Regulatory Inspection Scope of the Pharmacovigilance Inspection Conduct of the Pharmacovigilance Inspection The Pharmacovigilance Inspection Report Corrective actions following a Pharmacovigilance Inspection