WEDNESDAY 30 JANUARY (OPTIONAL - RSAC PLUS OPTION - REGISTER SEPARATELY)

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1 WEDNESDAY 30 JANUARY (OPTIONAL - RSAC PLUS OPTION - REGISTER SEPARATELY) COMMON SLOT - PHARMACOVIGILANCE & REGULATORY AFFAIRS CONFERENCE 14:00 PHARMACOVIGILANCE BEYOND THE PATIENT SAFETY DEPARTMENT Chair Jana Brajdih Cendak, Billev Pharma East 15:30 NETWORKING COFFEE BREAK 16:00 RISK MANAGEMENT PLAN WORKSHARING Chair Kora Doorduyn-van der Stoep, CMDh member/senior Policy Adviser, MEB (NL) 17:30 CLOSURE OF THE DAY FOLLOWED BY NETWORKING COCKTAIL RECEPTION THURSDAY 31 JANUARY - 18 th REGULATORY AND SCIENTIFIC AFFAIRS CONFERENCE 08:00 REGISTRATION AND NETWORKING WELCOME COFFEE 09:00 OPENING ADDRESS Marc-Alexander Mahl, President of Medicines for Europe, Fresenius Kabi 09:10 GLOBALISATION Chairs TBN The session will address several aspects of globalisation and their impact on generic medicines manufacturers and authorities: the broad implications of globalisation on development and international filing strategy, the benefits of more dialogue with regulators from key regions on global development, compliance, authorisation and supply chain management to facilitate the access to generic medicines globally and to minimise supply disruption. Tackling the effects of the globalisation of generic companies challenges, opportunities and priorities Challenges and opportunities of globalization in development, authorisation and supply chain of generic medicines EU Regulatory dialogs with international regulatory partners- their contribution to respond to current challenges Industry s product development and international filing strategy: what would make a real difference? How can various international initiatives help in increasing access to generic medicines globally? Q&A Session with a panel composed of session speakers, Andrzej Rys, DG SANTE EC, Guido Rasi, EMA, Maryll Toufanian, FDA, US (INV), Peter Bachmann, BfArM (DE), Emer Cooke, WHO (INV), Susanne Keitel, EDQM Industry representatives: Marc-Alexander Mahl, Fresenius Kabi, David Gaugh, Association of Accessible Medicines (AAM), US; Neeraj Sharma, Sun Pharma 10:30 NETWORKING COFFEE BREAK Medicines for Europe Rue d Arlon Brussels - Belgium T: +32 (0) F: +32 (0) P a g e 1

2 11:00 COUTDOWN TO BREXIT Chairs Nick Littlebury, Deputy MD of Diamond Pharma Services and Beata Stepniewska, Deputy Director General, Head of Regulatory Affairs, Medicines for Europe Only two months are left to the date of UK leaving the European Union. Is there a full clarity how to operate in the new framework in the EU and the UK? This session will give an opportunity to clarify last outstanding issues to be ready by 29 March 2019 and explain the meaning of the withdrawal agreement. The session will also cover new way of operating in the EU/ UK after Brexit. Possible future relationship between EU and UK will be also discussed. Are we ready for Brexit? - an opportunity to clarify last outstanding issues Final outcome of negotiations: what the consequences are on pharmaceutical companies operations? New way of operating in the EU/ UK after Brexit. Possible future relationship between EU and UK Move of the EMA to Amsterdam- impact on the EU regulatory network and cooperation with the industry Views from the Authorities & Industry: Andrzej Rys, EC, DG SANTE, Rita Purcell, HPRA, IE, CMDh, Marie-Helene Pinheiro, EMA, Keith McDonald, MHRA, UK and the industry: Paul Fleming, BGMA, Britt Vermeij, TEVA 12:30 NETWORKING BUFFET LUNCH 13:45 ENVIRONMENTAL RISK ASSESSMENT Chair TBN The Guideline on Environmental Risk Assessment (ERA) of Medicinal Products for Human Use has now been available for 10+ years. With the experience that has been gained, scientific developments and anticipated changes due to the Commission Strategy on Pharmaceuticals in the Environment, it is clear the existing framework will change. What is the best, risk-based approach that will ensure the environmental impact is minimised and at the same time ensures timely and continues access to the medicines? Need for a multi-stakeholder collaboration. Environmental Risk Assessment (ERA) of Medicinal Products for Human Use The latest status and views from national and European regulators/policy makers and possible/upcoming changes The industry proposal on enhancing Environmental Risk Assessment o What are possible challenges when moving forward? o What are the open questions still to be addressed? Ines Rönnefahrt, German Environment Agency, UBA, DE Jon Peers, Teva (INV) Jason Snape, AstraZeneca 15:00 NETWORKING COFFEE BREAK P a g e 2

3 15:30 SUPPLY CHAIN MANAGEMENT Chairs Brendan Cuddy, Head of Manufacturing Quality and Supply Chain Integrity, EMA and Mechthild Sander, Chair of the Quality & Compliance WG Medicines for Europe, AET The interplay between GMP and regulatory obligations related to APIs Finding the right balance to allow compliance, transparency and operability Managing API Supply Chains o Key challenges from the generic medicines industry perspective - TBN o How to maintain oversight of a globalised and fragmented supply chain authorities perspective - Andreas Sundgren, NOMA, NO Chair of EMA IWG/QWP group on QP declaration Maximising the value of the CEP for the API related variations: CMDh EDQM project on CEP - Nienke Rodenhuis, MEB & Hélène Bruguera, EDQM Optimisation of the ASMF assessment update on CMDh WG activities - Nienke Rodenhuis, MEB QA with session speakers and panellists Marieke van Dalen - APIC (INV) 17:00 CLOSURE OF THE DAY Beata Stepniewska, Deputy Director General, Head of Regulatory Affairs, Medicines for Europe 19:15 CONFERENCE DINNER FRIDAY 1 FEBRUARY 08:00 NETWORKING COFFEE 09:00 TELEMATICS & REGULATORY EFFICENCY Chair Remco Munnik, Chair of the Telematics WG Medicines for Europe, Asphalion This session will cover the latest developments and provide an update of the ongoing telematics projects and how regulatory efficiency can be achieved by using telematics tools. Shaping the digital future Target Operating Model (TOM) - concept, status and potential impact of implementation - Georg Neuwirther AGES, AT o Impact on Industry - Practical examples and case study Lee Bridgen, Mylan (INV) Digital Marketing Authorisation Holder GLOBAL DEVELOPMENT & GLOBAL COMPARATOR PRODUCT Chair Susana Almeida, Clinical Development and Safety Director, Medicines for Europe This session will discuss what needs to be done to move towards true global development for generic/ complex generic medicines. Global development for generics/ complex generics- can a dream come true? Learnings from the biosimilar framework Perspective from a regulator on global comparator products for bioequivalence studies The opportunities and challenges that a global development could bring to the industry What is needed to make a dream come true? P a g e 3

4 o How to navigate among all portals and databases? Anjana Pindoria, Extedo How can use of telematics projects optimise our day-to-day regulatory activities? Kevin Horan HPRA, IE & and Caroline Kleinjan, Sandoz o Current Status of SPOR and IDMP o Possible contribution to the regulatory optimisation EU Telematics Strategy way forward to Georg Neuwirther AGES, AT & Remco Munnik, Asphalion Speakers: Suzette Kox, Medicines for Europe Alfredo Garcia Arieta, AEMPS, Spain Maryll Toufanian, FDA, US (TBC) Gerald Beuerle, Teva lists: Emer Cooke, WHO (INV), David Gaugh, Association of Accessible Medicines (AAM), US 10:45 NETWORKING COFFEE BREAK 11:15 INFORMATION TO PATIENTS MEDICAL DEVICES & COMBINATION PRODUCTS Chair Kevin Airey, Mylan & TBN from NCA This session will cover various aspects of the electronic product information, as a follow up of the last years discussion and the EMA workshop end of Nov 2018: What are the key principles stakeholders agreed to, when moving from paper to digital? What is the common standard that will ensure everyone is traveling in the same direction? Which are the immediate next steps, who will take the lead and what are the proposed timelines? What is the role of each of the stakeholder to ensure the transition runs smoothly? Representative from the HMA Working Group: Nanneke Hendricks, MEB (INV) Regulatory authorities representative from the Standard Group (TBN) Industry - Katarina Nedog, Sandoz and Anjana Pindoria, Extedo Patients and pharmacists representatives Chair Paul Scannell, Chair of the Medical Devices Task Force Medicines for Europe, Mylan (INV) This session will cover the current status of the Implementation of the Medical Device Regulation- how is it going to affect combination products? What is the status on the implementation process of the new Medical Device Regulation (REGULATION EU 2017/745) with a special focus on Article 117? What is the future impact on combination products? Maria Carleton, Food and Veterinary Office, DG SANTE (TBI) Representative of Medicines Authorities Bei Ma, BSI (INV) Judit Javor, Pharma Patent (INV) 12:30 NETWORKING BUFFET LUNCH P a g e 4

5 14:00 PUT YOUR QUESTION TO THE REGULATORS 2019 Chairs Laura Oliveira Santamaria, Chair of the CMDh, AEMPS (ES) and Caroline Kleinjan, Chair of the Regulatory and Scientific Affairs Committee, Sandoz An opportunity to address questions to the European Regulators on various regulatory issues. Questions should be formulated generally, without reference to a given product/procedure and should be sent 2 weeks in advance to beata@medicinesforeurope.com Q&A Session with representatives from the EU authorities: Susanne Winterscheid, BfArM (DE) Marta Marcelino, INFARMED (PT) (INV) Kora Doorduyn-van der Stoep, MEB (NL) Jitka Vokrouhlická, SUKL (CZ) Ana López de la Rica Manjavacas, AEMPS (ES) 15:30 END OF CONFERENCE COFFEE Follow the event on twitter #RAC19 For further information MEDIA PARTNERS P a g e 5