Advanced European Regulatory Affairs

Transcription

1 Update on the developments in Europe for Regulatory Affairs and the impact on product development and life cycle management Course Language: English 210 Early Bird discount for enrolment by 7th March 2018 H10 Urquinaona Plaza Plaça Urquinaona, 2 E Barcelona, Spain Wednesday 4 and Thursday 5 April :30-18:00 For additional information: +39 (0)

2 Introduction During this course you will get an advanced introduction and insight in the challenging environment of EU regulatory legislation and practical advice for work in the future. In addition, an update on the latest developments and impact on the daily activities of a pharmaceutical company will be provided. As a result of the training you should be able to avoid pitfalls and compliance issues with the latest European regulations and optimize the effectiveness of your Pharmacovigilance system. To whom it may concern Regulatory Affairs Manager, Officer and Specialist Quality Manager Development Pharmacist Pharmacovigilance Manager Project Manager working for pharmaceutical company and CROs. Type of Training Presentation, including practical session of business cases and questions from audience Agenda Day 1 Day 2 9:00-9:30 Participants registration 9:00 Course commences 9:30 Course commences 11:00-11:15 11:00-11:15 13:00 Lunch 13:00 Lunch 15:45-16:00 15:45-16:00 17:30 Q&A and Conclusion 18:00 End of day 1

3 Programme Review European Regulatory Affairs legislation Course language: English Managing strategies based on to European regulatory affairs Understanding the new regulatory procedures - What s new in Regulatory Affairs? - Transparency policy - CTA and Clinical data entry (EudraCT) - PRIME / adaptive licensing - ISO IDMP - Falsified Medicine Directive and impact on RA EU procedures, CMDh guidance and Q&A documents: - National / MRP/ DCP / CP - Variations - Renewals Advanced RA in EU: - Orphan Drug Designation - Pediatric Investigation Plans - Scientific Advice / protocol assistance - IMPD / IB - ATMPs: Cells, tissues, organs, gene therapy, cloning - Biosimilars Electronic Submission in EU ectd / NeeS CESP / Gateway xevmpd / ISO IDMP

4 Lecturer's Bio Lidia Canovas, Director of Regulatory Affairs, Asphalion S.L. Lidia has a Pharmacy and MBA degree. She has fifteen years overall experience in pharmaceutical industry, ten years as Regulatory Affairs Director and four years as Vice-Director for Research and Development. She has been working at Asphalion for ten years as General Manager and Director of Regulatory Affairs. As director of Regulatory Affairs at Asphalion, Lidia is responsible for the overall quality of the Regulatory and Scientific services that Asphalion provides to a large number of international and national clients. Remco Munnik, Regulatory Information Director, Asphalion S.L. Remco has a Bachelor degree in a study of Management, Economics & Law. He has over fifteen years experience in submission procedures EU/US, electronic submission and regulatory data management. Since 2011 Remco works for Asphalion, an international Regulatory Affairs consultancy, based in Barcelona and Munich. Within Asphalion, Remco is responsible for global esubmission projects (ectd, NeeS, RIM, xevmpd and ISO IDMP). His team is working on CP/DCP/maintenance for EU and FDA (IND/NDA/BLA/maintenance). In addition a dedicated team is focussed on xevmpd submission and IDMP implementation. In addition he is the chairman of Medicines for Europe Telematics working group and in direct contact with EMA and NCAs for the esubmission roadmap, ectd specification, validation criteria, eaf, CESP, Gateway, xevmpd and ISO IDMP. Participant experience Participants need to have a basic understanding of EU regulatory procedures. At the end of the training, you will be able to: Understand the complex EU legislation and requirements and increase your knowledge of the latest developments in order to ensure compliance in future.

5 TO REGISTER FOR THE COURSE YOU CAN FILL IN AND SEND THE REGISTRATION FORM OR DIRECTLY REGISTER ONLINE: REGISTRATION FEES: Methods of payment Early bird: 1570,00* until 07/03/2018 Ordinary: 1780,00* Freelance Academy Public Administration: 890,00* *For Italian companies: + 22% VAT The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. The full amount must be paid on registration to EasyB s.r.l by bank transfer or by credit card. If paying by bank transfer please attach proof of payment to the registration form. Bank transfer payable to: EasyB S.r.l. Via Roma, Alzano Lombardo (BG) P. IVA Banco BPM - Filiale di Carobbio Degli Angeli IBAN: IT81 F SWIFT CODE: BAPPIT21AY5 For additional information: Secretarial office Phone Fax Mail LS Academy +39 (0) Please fill in and send: (+39) Surname Company Address City Tel. Special Dietary Requests Invoicing details Company name Address Mail address (If different) City VAT number Name Job title Post code Fax. Post code or register online. Terms & conditions Terms of payment The registration fee must be paid at the time of registration. Confirmation of course admission will be given on receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants. Cancellation Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the course date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities. LS Academy reserves the right not to accept registrations not compatible with the event s target audience. The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course. LSACADEMY.com Date Signature