Generics & Biosimilars PPM Summit Munich (Online)
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Schedule
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· Stage
KEYNOTE: NEW TRENDS IN THE FIELD OF BIOSIMILARS & GENERICS
Sameer Agarwal, CEO & Managing Partner CSA Healthcare, Germany
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· Stage
CASE STUDY: OPPORTUNITIES AND CHALLENGES FOR DIFFERENT GENERIC DRUG TYPES
Stefanie Amend-Mall, Global Project Manager Sandoz
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· Networking
NETWORKING BREAK
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· Stage
PANEL DISCUSSION: 505(b)(2) HYBRID DRUGS OPPORTUNITIES
Ana Gavaldá, Portfolio Management Specialist Annion, Spain | Paras Vasanani, Director & Head Business Development, Portfolio Strategy, Kashiv Biosciences, India
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· Stage
PRESENTATION: VALUE ADDED MEDICINES OPPORTUNITIES
Ana Gavaldá, Portfolio Management Specialist Annion, Spain
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· Networking
NETWORKING LUNCH
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PANEL DISCUSSION: REGULATORY CHALLENGES OF COMPLEX GENERICS AND COMBINATION PRODUCTS AND HOW TO DEAL WITH THEM
Pallavi Trivedi, Head of Regulatory Affairs | Marjan Dzeparoski, Pharmacovigilance Manager | Neelu Goel, Associate Director - Regulatory Affairs & Compliance
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KEYNOTE: BIOSIMILARS – OPTIMIZING MARKET ACCESS
Klemen Spaninger, Senior Director, Head of Project Management Office, Global Program Lead Fresenius Kabi, Switzerland
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PANEL DISCUSSION: BIOSIMILARS – OPPORTUNITIES, CHALLENGES, AND OUTLOOK
Paras Vasanani, Kashiv Biosciences | Edric Engert, Abraxeolus Consulting | Klemen Spaninger, Fresenius Kabi | Dinesh Kundu, QbD Biosciences
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PANEL DISCUSSION: DEVELOPING PRODUCTS THAT QUALIFY FOR MULTIPLE MARKETS
Klemen Spaninger, Fresenius Kabi | Marjan Dzeparoski, Bionika Pharmaceuticals | Lalit Baregama, Cadila Pharma | Dinesh Kundu, QbD Biosciences
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· Stage
WORKSHOP: SECRETS OF SUCCESSFUL PROJECT TEAMS: MANAGING BIAS IN PROJECT ORGANIZATIONS FOR EFFICIENT DECISION-MAKING
Mithun Mridha, PPM Practice Manager | Enterprise Architect | Intercultural Enthusiast, International Speaker, France
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· Stage
CASE STUDY: JOINT DEVELOPMENT GENERIC PROJECTS BETWEEN TWO COMPANIES - HOW TO ACHIEVE COMMON OBJECTIVES AND SATISFY BOTH PARTIES?
Michal Urban, Project Management & Launch Preparation Lead, Sanofi, Czech Republic
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KEY ELEMENTS OF TRANSITION FROM PORTFOLIO SELECTION TO LAUNCH EXECUTION - ONE OF THE SUCCESS FACTORS FOR BEING A DAY 1 OR FIRST TO MARKET
Reethu Patel, Global Product Launch Manager Sandoz, Germany
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· Networking
NETWORKING BREAK
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· Stage
PANEL DISCUSSION: INTERNAL COOPERATION TO ENSURE SUCCESSFUL PRODUCT LAUNCH
Reethu Patel, Global Product Launch Manager | Bahadir Cakmak, Global Portfolio Pipeline Manager | Stefanie Amend-Mall, Global Project Manager - Sandoz
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· Stage
CROSS INDUSTRY PANEL DISCUSSION: INTERNAL COOPERATION TO ENSURE SUCCESSFUL PRODUCT LAUNCH
Reethu Patel, Sandoz | Bahadir Cakmak, Sandoz | Stefanie Amend-Mall, Sandoz | Michal Urban, Sanofi | Klemen Spaninger, Fresenius Kabi
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· Networking
NETWORKING LUNCH
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· Stage
KEYNOTE: DIGITAL HEALTH AND GENERICS/ BIOSIMILARS BUSINESS
Erez Hybloom, Independent Consultant, Former Global & Europe Commercial Portfolio Management Teva, Netherlands
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PANEL DISCUSSION: PRODUCTIVITY AND EFFECTIVITY - MOST OFTEN DELAYS IN GENERIC FORMULATION PROJECTS
Yasser Gawad, Teva Pharmaceuticals | Daniela Braun, Celonic Group | Rachna Khanna, Dr. Reddy's Laboratories | Varada Bapat, Wockhardt
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PRESENTATION: ACQUISITION AND OWN LAUNCH OF NICHE PRODUCTS
Detlef Behrens, Founder, Baypharma, Germany
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PANEL DISCUSSION: EMERGING MARKETS: OVERVIEW OF EMERGING MARKETS PANEL DISCUSSION
Stefanie Amend-Mall, Global Project Manager, Sandoz | Michal Urban, Project Management & Launch Preparation Lead, Sanofi, Czech Republic
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· Networking
NETWORKING BREAK
Speakers
Reethu Patel
Global Product Launch Manager | Sandoz Germany
Pallavi Trivedi
Head of Regulatory Affairs | Warwick Healthcare United Kingdom
Rachna Khanna
Head Product Portfolio | Dr. Reddy's Laboratories India
Lalit Baregama
General Manager Global Business Development | Cadila Pharma India

Marjan Dzeparoski
Regulatory Affairs and Pharmacovigilance Manager | Bionika Pharmaceuticals Macedonia
Booths
Decision Analysis Portfolio Management Masterclass
Led by industry veteran Dr. Richard Bayney
Project Revolution Masterclass
Led by Project Management world champion, Antonio Nieto-Rodriguez

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