Dr Alan Touch

Curriculum Vitae Summary Name: Dr Alan Touch Email: drajtouch@gmail.com Cell: +1 919 601 0374 Current location: Raleigh, NC Education: Doctor of Optometry (OD) from Indiana University Bachelor of Arts in Psychology from the University of Iowa.

SME Hands-On Leadership Expertise: Early Stage/Mid-Size Regulatory/Clinical Development Strategic Milestone Roadmap Therapeutic Program Management & Quality Management Leadership IVD and Diagnostics Project Management and Strategic regulatory leadership Mult-pharma/Device Project Management and Strategic Regulatory Leadership Regulatory Experience including Compliance/Remediation for QMS and Technical Files.

Regulatory Medical Writing for submissions and compliance reporting Clinical Quality Management Planning and implementation Specialized leadership in developing the Strategic Regulatory and Clinical Trial Roadmap. Complete integration with the Business Model for the early stage and mid-sized healthcare companies. Global Regulatory/Clinical Development SME, Medical Device, MDR/IVDR, targeted pharma and IVD diagnostics/combination products, targeted pharma and medical device US FDA submissions and compliance. Small Molecule CDMO Chief Science Officer. Functional Clinical Development and St SME for Ophthalmology, Neurodegenerative Disease, Oncology Radiation Therapy, and Dermatology. Multiple Therapeutic areas clinical and regulatory for pharma and medical devices. Thirty years of strategic product development, regulatory leadership and hands-on experience leading teams for Sponsors and CROs in medical device, pharma and IVD/diagnostics (including combination products), medical device product development management, global regulatory affairs management, regulatory medical writing, pharma and device clinical trial design and protocol development, drug development biomarker tool models, select global therapeutic pharma clinical trials, specialized IVD clinical trial models and budgets, and clinical quality management planning including clinical GCP/ GLP compliance and audits and CAPA or other remediation. CER/PER medical writing including PMSR PMCFP/R. Senior Advisor with success boosting productivity and streamlining procedures for organizations. Focused on smoothly overseeing financial, personnel and operational facets. Expertly balanced RoadMap targets planning resources and milestone-optimized long-term success. Determined as Advisor with success in boosting productivity and streamlining procedures for organizations. Focused on smoothly overseeing financial, personnel and operational facets. Expertly balanced targets with resources and optimized long-term success. a Determined [Job Title] with success boosting productivity and streamlining procedures for organizations. Focused on smoothly overseeing financial, personnel and operational facets. Expertly balanced targets with resources and optimized long-term success. Successful [AreA of expertise] business professional with demonstrated track record consulting. Exceptional program, team and project manager. Skilled at mentoring staff, integrating ideas and customizing approaches to support specific means and goals. Reliable business professional with experience in project management, process improvement and financial analysis. Proven track record of successfully streamlining business operations and reducing costs. Adept at analyzing data to identify trends and developing strategies to improve efficiency. Forward-thinking Operations Specialist bringing [Number] years of expertise in [AreA of expertise] for [Industry] sector businesses. Cultivates rapport with individuals to optimize project goals and output, resolve complex problems and deliver innovative improvement strategies. Proficient in [SoftwAre] and [SoftwAre]. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

• Ocular Surface Disease: The Inflammatory / Oxidative Stress Cascade
• Tear Chemistry and Presbyopia – Impact on Dry Eye and Contact Lenses
• International Regulatory Pathways for Medical Devices: Understanding Changing Landscape to Develop Go-to-Market Strategies
• Latin American Medical Device and Diagnostics International Strategies
• Medical device clinical trials in China - The Real World - A strategic regulatory and clinical trial model
• Diagnostic Biomarker Verification and Validation Clinical Trial Adaptive Design Models for Speed to Market Strategies
• The Real World of Clinical Trials for Medical Devices in China – a strategic regulatory and clinical trial approach
• Device Drug Delivery Future Directions and Developments
• 21st Century Cures Act – A Major legislative action by Congress affecting the FDA and Industry – Part I
• 21st Century Cures Act – A Major legislative action by Congress affecting the FDA and Industry – Part II
• 21st Century Cures Act – Impact of the Drug Development Tool and Other Clinical Considerations
• Clinical Trial Good Clinical Practice (GCP) – Are You Ready?
• Five Ways Sites Can Prepare for Implementation of the 21st Century Cures Act
• Good Clinical Practice (GCP) Clinical Trial Audit of Personalized Medicine Site and CAPA Implementation – A Case Study
• EU MDR Global Remediation – An Aesthetic Device Case Study
• EU MDR QMS Remediation – A global harmonization Case Study
• Responding to Coronavirus Ventilator Shortage, A directional review