PHARMA LAWCONVENTION

Transcription

1 2-3 MARCH 2017 AUSTRIA TREND HOTEL SAVOYEN ****S VIENNA, AUSTRIA 6 th ANNUAL PHARMA LAWCONVENTION GOLD SPONSOR SILVER SPONSORS BRONZ SPONSOR OFFICIAL CARRIER IN PARTNERSHIP WITH ENDORSED BY

2 Why should I attend Pharma LawConvention? - overview from industry top experts - topics addressed from EU and national perspective - checklist for Legal Counsels, Compliance and Regulatory positions - more interaction, less time for presentations, more for panel discussions - case studies from different European countries - business cocktail reception in relaxed atmosphere (DAY 1) 6 th Convention program addresses major legal, regulatory and EU legislation challenges in the pharmaceutical industry. Please expect presentations, discussion and workshops on topics like Competition, Compliance, Transparency, Medicines Verification System, Data Privacy and Mergers/Acquisitions. Several important European pharmaceutical associations EFPIA, EGA, PGEU, GIRP, EAEPC and WHO are already cooperating with us on this event for several years. SUPPORTING ASSOCIATIONS MEDIA PARTNERS

3 DAY 1: THURSDAY 2, MARCH :00 8:30 9:30 11:15 11:45 13:00 Welcome Coffee and Registration of Participants Keynote address Martin MUNTE, President of Pharmig, CEO Amgen GmbH "Pharma industry challenges in 2017" MORNING SESSION 1: DISCLOSURE - FIRST EXPERIENCE INTERACTIVE PANEL DISCUSSION - Regional overview - First experience & feedback - Local obligations, regulatory healthcare engagements - The differences across region - event reporting, contract reporting - External reaction to disclosure (consent rate, media, medical councils) - Best practices Jan Oliver HUBER, Secretary General, PHARMIG Austria Katarina SLEZAKOVA, Executive Director, AIFP Slovakia Jakub DVORACEK, Executive Director, AIFP Czech Republic Bogna CICHOWSKA-DUMA, Director General, INFARMA Poland Thomas STRAUMITS - Chairman AIPM Hungary & Managing Director, MSD Sebastian GRUSON - Boehringer Ingelheim, Head of Legal & Compliance, Central, Eastern & South East Europe, Russia, Central Asia, Israel, Switzerland MORNING SESSION 2: MEDICINES VERIFICATION IN EUROPE INTERACTIVE PANEL DISCUSSION - Falsified Medicines Directive & Delegated Regulation - European Medicines Verification System and Organization - Who has to pay what? - Status of national implementation Impacts of serialization regulations from a manufacturer s perspective: - Technical upgrade of packaging capabilities and IT infrastructure - Changes in shipping and distribution processes - Challenges in the data transmission to national systems Monika DERECQUE-POIS, Director General, GIRP- European Healthcare Distribution Association Sebastien MAUEL, Head of Serialization and Product Security; Serialization Program Director, FERRING Pharmaceuticals Jan Oliver HUBER, Secretary General, PHARMIG Austria Katarina SLEZAKOVA, Executive Director, AIFP Slovakia Jakub DVORACEK, Executive Director, AIFP Czech Republic Michal KACZMARSKI, Compliance Lead and Data Protection Officer, Amgen Networking Business Lunch

4 DAY 1: THURSDAY 2, MARCH :15 15:45 16:00 17:30 MERGERS & ACQUISITIONS AND POST-MERGER INTEGRATION - Special heads-up in the Due Diligence processes and at Closing/Signing - The transfer of marketing authorizations and the consequently necessary re-labeling - Challenges arising from the expectations of the stakeholders - M & A trends in the pharma industry - From a Start-up to an IPO - Success and challenges - How to make post-merger integration successful Christoph MAGER, Partner, DLA Piper Elisabeth STICHMANN, Partner, DLA Piper Claudia HANDL, Director Public Affairs, Pfizer Austria Michael WEISMANN, Partner, Deloitte Ralf SCHMID, CFO of F2G Ltd, (previously CFO of NASDAQ listed company Nabriva) WORKSHOP: ADVERTISING & MARKETING Limits and Borderlines - Is your marketing activity compliant? Workshop with country sub-sessions. Austria: Sabine FEHRINGER, Monika HUPFAUF, Elisabeth STICHMANN Czech Republic: Petr SAMEC Germany: Burkhard FUHRMEYER, Thilo STREIT Poland: Andrzej BALICKI Romania: Livia ZAMFIROPOL Cocktail Reception DAY 2: FRIDAY 3, MARCH :30 9:00 Welcome Coffee and Networking Keynote address Richard BERGSTROM, Pharma Sector Lead, SICPA, former Director General EFPIA "The Golden Twenties: how the next decade will make a real difference for people's health"

5 DAY 2: FRIDAY 3, MARCH :00 11:40 12:00 13:45 DATA PRIVACY (INTERACTIVE PANEL DISCUSSION) - The impact of the new EU data protection regulation - What does it mean to implement a privacy by design and by default in pharma sector - Data sharing: Confidential vs. Right of Access - the challenges related to the requirements in the field of the international data flow - the challenges related to accessing the personal data in general - Data Protection Issues - Data Monitoring - Providing Data to the third parties Maria Chiara ATZORI - Head of Data Privacy, Novartis Switzerland Monika MASKOVA - Attorney at law, PRK Partners Andrea DILLENZ - Data Protection Officer RCV, Boehringer Ingelheim Michal KOSCIK - In-House Lawyer and Researcher at Masaryk University PRICING & REIMBURSEMENT Sabine VOGLER - Head of the WHO Collaborating Centre, Head of the Pharmacoeconomics Department Gesundheit Österreich GmbH (GÖG / Austrian Public Health Institute) Policies to ensure affordable access to new high-priced medicines - Challenge of high-priced medicines: European evidence - European mapping of existing pricing and reimbursement policies for high-priced medicines - Limitations and options for the future Yannis NATSIS - Policy Manager for Universal Access & Affordable Medicines, European Public Health Alliance (EPHA) Access to medicines in Europe: New rules of the game are needed - Update on recent EU political developments - Regional intergovernmental initiatives to tackle the issue of access to innovation - Intellectual property related incentives & medical innovation - Affordable medicines & the drug regulatory framework in Europe Barbara MAJCEN - General Counsel, CEE & SEE, Teva Pharmaceuticals Peter L ECLUSE - Partner, VAN BAEL & BELLIS - Sovereignty of Member States in pricing and reimbursement matters; - Limits on sovereignty of Member States in pricing and reimbursement matters; Directive 89/105 (transparency Directive) Free movement rules Competition rules - Cooperation of Member States in pricing and reimbursement matters - Cooperation of Member States and EU powers in adjacent areas Innovation horizon scanning Health Technology Assessment Networking Business Lunch End of Convention