Latin America: An Evolving Regulatory Environment September 15, Mapi 2015, All Rights Reserved

Transcription

1 Latin America: An Evolving Regulatory Environment September 15, 2015 Mapi 2015, All Rights Reserved

2 Upcoming Live Webinar Event: Key Information Featured Webinar Hosts Silvia Bendiner Director of Strategic Regulatory Affairs and Life Sciences, Mapi Group Fernando Ferrer Life Sciences Expert in Global and Latin American Business Expansion and Growth; Mapi Group Consultant and Guest Co-Host Important Webinar Information Tuesday, September 15th, :00 am, EDT (New York, GMT-04:00) 3:00 pm, BST (London, GMT+01:00) 4:00 pm, CEST (Paris, GMT+02:00) Webinar Registration Page (Share this with Colleagues!): 2

3 Webinar Host Silvia Bendiner Director, Regulatory Affairs Latin America Ms. Bendiner has over 25 years of life sciences experience, including pharmaceuticals, biotechnology, medical devices, generics, nutraceuticals, nutritional supplements, translational therapy, herbal medicines and biologics. Ms. Bendiner joined OptumInsight (acquired by Mapi Group in December, 2014) at a time when the Company was expanding its expertise in the region which was directly driven by a strong interest and demand from Optum clients. Silvia brings a wealth of experience and a clear understanding of specifics of growing successful regulatory operations and understands the challenges of expansion in Latin America. Ms. Bendiner is an expert in the development of Regulatory and Marketing strategies for drugs and devices within international markets. Her expertise in Mexico, Puerto Rico and Latin America ranges from regulatory submissions to preparing market feasibility studies to negotiating distribution and partnership agreements. She has worked with small, mid-size businesses (including start-up companies) in developing business, commercial and operation plans, supported both pre and post product launch activities in various therapeutic areas. She has worked in the area of Clinical Development and Business Development with inlicensing expertise across Mexico and Latin America. Ms. Bendiner holds a Bachelors Degree in Languages and Sciences, and started her professional career as a simultaneous translator and interpreter in the US and Mexico. She is bilingual in English and Spanish, fluent in Italian and German with conversational skills in French and Portuguese. 3

4 Webinar Host Fernando Ferrer Managing Partner, Multinational Partnerships LLC Regulatory Services Consultant, Mapi Group Fernando Ferrer is a proven business leader in life science with experience across different corporate and cultural environments, and speaker in industry related events. Mr. Ferrer is based in the US, and due to his professional career he lived also in Spain, Switzerland, Argentina and Brazil, and besides his global roles, has had experience working directly with 30+ countries. Ferrer began his professional career in the chemical-pharmaceutical Swiss company Roche (F. Hoffmann-La Roche A.G.), where he had Latin American and global roles for diverse business units while living in different countries. Heading up his latest enterprise, Multinational Partnerships, LLC, he is focused on strategic planning and business expansion of life science organizations across Latin-American markets, and the development and management of business alliances among multinational and Latin American organizations for both, in business-to-consumer (B2C), and business-tobusiness (B2B) markets. In his academic role at RVCC, he serves as adjunct professor of management, international business and global strategic management. 4

5 Webinar Description This webinar will provide a current overview of the Latin American Regulatory environment with country specific regulatory requirements. The main focus will be on Argentina, Brazil, Mexico and Colombia. The presenter will share regulatory strategies, procedures and techniques explaining the utilization of ICH standards and compliance requirements for elaborating and processing regulatory submission dossiers for successful Market Authorization approval across the region. We encourage a Q&A session for sharing experiences and tips to successfully navigate the Latin American regulatory environment. 5

6 Key Discussion Points The Business opportunities of Life-Science in Latin America. The current business approach Overview of the Regulatory Process across the LATAM region Strategic Regulatory Filing The Do s and Don ts A practical approach Recommendations for inclusion of LATAM as part of a company s global regulatory strategy Question and Answer (Q&A) Session 6

7 What You Will Learn How to elaborate a Latin American regulatory dossier implementing a road map country/regional specific. Gain insights of the Do s and Dont s for dossier preparation, dossier filing activities while meeting the expectations of local Health Authorities to obtain Market Authorization approval. 7

8 About Mapi Group Founded 40 Years Ago Pioneered many of the practices that are now standard in the industry: Patient centered research PROs Linguistic Validation Acquired Registrat in 2010 pioneered registries Established Mapi Research Trust non profit information clearing house for researchers Services RWE conducting post approval studies Epidemiology consulting Patient Centered Outcomes Research Language Services Health Economics and Outcome Research Strategic Market Access 8

9 Market Adoption Peak Phase I - III 9

10 Mapi Group is uniquely able to do the things that CROs cannot... Pharma identifies Endpoint Strategy Pharma identifies COA options and begins licensing discussions Patient-Centered Outcomes Services Language Services Health Economic Outcomes Research Services Value Dossier and Strategic Market Access Services Real World Evidence Services 10

11 From Integrated to Integral The world s largest independent company exclusively focused on Health Research and Commercialization offering aligned services to support: Market Authorization Market Access Market Adoption 11

12 Integrating services to meet demand, Strategic Regulatory Services (SRS) Strategic Regulatory Services brings global leadership and deep regulatory knowledge through integrated consulting focused on maximizing value through its traditional regulatory consulting, pharmacovigilance services, clinical manufacturing and quality audits across the life sciences market. Regulatory Comprehensive knowledge and ability to navigate the complex regulatory/clinical approval process across international jurisdictions Quality Client assessment and improvement to meet safety requirements and ongoing monitoring of safety measurements Pharmacovigilance Industry knowledge and research to maintain compliance in an ever-changing environment Full service functional outsourced Regulatory group Global submissions and maintenance of marketed products Chemistry, manufacturing and controls (CMC) services Regulatory operations (traditional and electronic submissions and publishing) Global agency liaison and meeting preparation Information services (Freedom Of Information, literature searches, etc.) Quality system design and execution (pharma, biologics, devices) Due diligence audits & assessments Remediation assistance Training GMP, GCP Audits Full service functional outsourced Pharmacovigilance/Drug Safety department European Qualified Person for Pharmacovigilance Risk management plan development Adverse signal detection and management Preparation of regulatory reports Training Call Center 12

13 Health Research and Commercialization Mapi services support the acceleration of Treatment peak revenue Post approval requirements Payers & Endorsement bodies Advocates, prescribers & patients Regulatory requirements unlock potential The key to success is a strategy for regulatory commitments and commercialization Mapi delivers commercial value from your research investment 13

14 Mapi Health Economics & Outcomes Research (HEOR) Industry.Leadership Value Identification 35+ HTA environment reviews Insights into HTA decision making for biosimilars 35+ Global Value Dossiers Value Generation 150+ systematic literature reviews in a variety of therapeutic areas 85+ network meta-analyses / indirect treatment comparisons 80+ economic models: 18+ core cost-effectiveness models 47+ country adaptations 80+ HRQoL, PRO and ClinRO scales developed, including: 10+ simultaneous development / 20+ scales for clinical practice 20+ PRO Endpoint strategy conducted 20+ phase III trials PRO endpoints analyzed 100+ scales psychometrically validated 200+ publications in HEOR & PRO for the past 5 Value Communications 200+ submissions 45+ submissions to NICE, CVZ, AWMSG, G-BA & SMC 150+ submissions to HAS 20+ countries worldwide 39 dossiers intended to list a MEDICAL DEVICE 25+ budget impact models and country adaptations 14

15 Mapi Real-World Evidence (RWE) Industry Leadership Late-Phase Studies & Real World Evidence Registries Expanded access Post-authorization Safety Studies (PASS) Post-authorization Effectiveness Studies (PAES) Product Utilization Studies Observational/Non-interventional Studies Phase IV Studies Global Study Operations Patient Retention & Management Chart Review Survey Risk Management & Safety RMPs & REMS Regulatory Responses Aggregated Safety Reports Epidemiology Market Forecasts Literature Reviews Protocol Development Strategy & Consulting Training 15

16 Thank you Additional Questions? Ask our Webinar Hosts directly! Silvia Bendiner, Webinar Host: Phone sbendiner@mapigroup.com Fernando Ferrer, Webinar Host: Phone info@multinationalpartnerships.com Mapi 2015, All Rights Reserved