Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date New-Drug Development: Succeeding With the FDA Premier Consulting - Kristi Miller, Ph.D., Senior Vice President, Regulatory Affairs Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the s... 3 months ago | 47 mins New-Drug Development: Succeeding With the FDA Premier Consulting - Kristi Miller, Ph.D., Senior Vice President, Regulatory Affairs Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the s... 4 months ago | 43 mins Enabling efficient Submission Content Management & Publishing Agnes Cwienczek, Head of Product Management and Consulting at Amplexor Life Sciences Find out how companies can improve business agility by producing and managing compliant, high-quality submissions in a cost and time-efficient manner.... 8 months ago | 61 mins Development of Drug-Device Combination Products with codebeamer X Bernhard Müllinger, General Manager, Resyca and Danish Mairaj, Principal Engineer, Resyca Rescya is an innovative provider of advanced drug delivery technologies, focusing on user-friendly soft mist inhaler devices. As a company operating a... 4 months ago | 54 mins Control Risks Lurk at Every Step: Revealing Data and Process Risks in Regulatory Harry Chopra (AxiomSL), Abraham Teo (AxiomSL), Eli Feuer (AxiomSL), Thangaraja Nadaraja (PwC), Mike Meriton (EDM Council) In the world of regulatory reporting requirements, control risks lurk at every step — from data ingestion, enrichment and validation to sign-off and r... 1 year ago | 57 mins Optimise Your Regulatory & HTA Submissions with a Comprehensive Health Economic Michael Cook, Principal, Epidemiology Optimise Your Regulatory & HTA Submissions with a Comprehensive Health Economic & Epidemiologic Evidence Strategy Regulators and payers have placed ne... 5 years ago | 52 mins Optimise your Regulatory & HTA Submissions Michael Cook, Principal, Epidemiology Optimise Your Regulatory & HTA Submissions with a Comprehensive Health Economic & Epidemiologic Evidence Strategy Join us to learn best practices for ... 5 years ago | 53 mins Documentum for Life Sciences Regulatory Solutions – What’s New! What’s Next! Lena Shafir - Product Manager, Life Sciences Regulatory Solutions, Dell EMC Watch and learn how Documentum Research and Development (R&D) and Documentum Submission, Store and View (SSV) ensures alignment with global regulatory... 6 years ago | 45 mins IDMP from two perspectives: theory and practice Frits Stulp, Managing Director, Iperion Life Sciences Consultancy / Siniša Belina, Amplexor's Senior Life Sciences Consultant The second version of the EU IDMP Implementation Guide is expected to be published in December this year. This new release contains updates on the Med... 1 year ago | 59 mins Quality Management Crossroads Siniša Belina, Senior Life Sciences Consultant, Amplexor The complexity of everyday operations in the Life Sciences industry is constantly increasing. To keep up with the regulatory requirements while upkeep... 9 months ago | 61 mins Load more
