プロフィール詳細

プロジェクトを作成

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Dr. Nare S.に依頼

Armenia

More than 10 years of experience as Regulatory Affairs Specialist, Medical and Scientific Writer, Clinical Trial Consult

プロフィール概要

My science qualification is a Ph.D. in pharmaceutical science. My writing qualifications: - Writing in the Sciences Certificate (Stanford University, USA) - Writing Effective Grant Proposals (University of Colorado) - Health Writing Certificate (Health Writer Hub, Australia) - Grant proposal writing principles (NonprofitReady) Achievements: I have prepared a section of a grant outlining the work necessary to put together a CMC section for an FDA IND. I have done a grant proposal for Cardiac CT. Prepared and Submitted eCTD to the US (FDA), Canadian HA, and EU for approval of the dossier from my side. Published Articles: 1. "What is a regulatory dossier and what does it contain" 2. "How to prepare a Risk Management Plan (RMP)" 3. "GMP compliance for gene therapy with a focus on ancillary materials 01" 4. "SEO article for "Importance/Role of Technology Transfer in Pharmaceutical Contract Manufacturing'' 5. "SEO article for ''Botched Breast Augmentation'' 6. "How biotech firms can ensure regulatory compliance in 2022" 7. "The role of brain activity in human longevity" 8. "Clinical Manuscript for Nutraceutical Product" 9. "The EU Environmental Risk Assessment (ERA) for medicinal products" 10. "Cancer vaccinations (relates to using of D Crypt)-comments NM" 11. "Tissue engineering" 12." Biomanufacturing using saccharomyces as a host organism" 13. "Synthetic Biology and Metabolic Engineering for the Development of Yeast and Bacteria" 14." Improving manufacturing process efficiency to leverage the better (COGs) and Operating costs" 15. " Immune checkpoint inhibitors Target novel therapeutic antibodies to maintain self-tolerance and mitigate physiological immune" 16. "ADCs are considered safer and more effective than traditional antibodies for the treatment of cancer as next-gen therapeutics" 17. "Clinical Significance of Slow Intravenous Infusion Versus Rapid Push Administration Methods: A Systematic Review and Meta-Analysis IV Administration Methods and Clinical Outcomes" Manuscripts: 1. Systematic Review of the Randomized Control Trials that evaluates the effects of Corticosteroid Therapies for Covid-19 Treatment 2. Risperidone and Aripiprazole in Children with Autism Spectrum Disorder Substantially Improves Core Signs and Symptoms in Combination with Standard Supportive Therapies: A Large, Single-Center, Retrospective Case Series 3. An Investigational Medication, in Patients with Active Rheumatoid Arthritis in the Knee, Hand, and Neck: A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study 4. The EU Environmental Risk Assessment (ERA) for medicinal products 5. Manuscript for a case-control study of risk factors of Malnutrition in Elderly residents of Long-term Care Facilities Recently, I was engaged in literature and scientific research for these main topics: 1. "COVID-19 Vaccine Deep Cold Storage" 2. "Role of Maternal Stress in Foeta Development - Association with Child Interaction at Pre-School Age" 3. "Review of the current scientific and evidence base of Longevity research" 4. "Literature Research for Cholangiography" 5. "Impact of the COVID-19 Pandemic on Clinical Practice, Medical Education, and Research Worldwide" 6. "The impact of the Inflation Reduction Act on the drug development pipeline with a focus on clinical trials" 7. "Research of evidence for peptide therapy" What can I do for you? - Medical writing (manuscripts, slide decks, abstracts, HCPs training material, marketing collaterals, decision aids for patients and HCPs) - Scientific writing (review articles, blog articles, white papers, grant proposals, press releases, product development documents) - Editing and proofreading medical, academic, and scientific documents - Literature search and reference organization - Scientific and technical consulting - Science communication strategy consulting Regulatory Affairs Specialist (with specific knowledge of CMC). Clinical trial Consultant. The primary responsibilities are: - Work with CTD dossier Module 1 through Modul 5 - Coordination of the project (compilation and binding of the regulatory dossiers for the new application of marketing authorization/renewal/variation; submission of products registration application; literature review; labeling & artwork) - Prepare new CMC applications (IND/NDA, IMPD/MAA, NDA/ANDA, BLA) for marketing authorization/renewal/variation of medicinal products; Rx and OTC, medical devices, cosmetics, and food supplements for regulatory submission - Clinical trial applications for medicinal products and medical devices. Directives and Regulations for conducting Clinical Trials worldwide and writing and reviewing Investigator Brochures, protocols, CRF, IP, etc. based on country-specific requirements. - Regulatory consulting related to EAEU regulation - Adhere to the required use of technical tools, through the use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved Do not hesitate to contact me to discuss potential collaborations. I am looking forward to hearing from you!

専門分野

• ★ Regulatory Affairs
• ☆ STEM
• ☆ Biotechnology & Bioengineering
• ☆ Industrial Biotechnology
• ☆ Pharmaceutical Sciences
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Medicine
• ☆ Clinical Trials
• ☆ Medical Sciences
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Product Evaluation
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Product Launch Support
• ☆ Research
• ☆ Literature Search
• ☆ Regulatory Writing
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ SEO Medical Writing
• ☆ Medical Copywriting
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ White Papers
• ☆ Science Communication
• ☆ Literature Review
• ☆ Copywriting
• ☆ Blog Posts
• ☆ Product Descriptions
• ☆ Scientific Proofreading & Editing
• ☆ Grant Writing

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting

Research Market Research, Meta-Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

Product Development Formulation, Material Sourcing, Manufacturing, Concept Development

職務経験

RA specialist

FMD Services LP

1月 2018 - 現在

学歴

PharmD (Doctor of Pharmacy)

Yerevan State University, Yerevan, Armenia Faculty of Chemistry

9月 2006 - 9月 2011

認定資格

• Proposal Writing

  NonprofitReady

  12月 2021 - 現在

• Becoming a Great Leeder - Leadership skills

  NonprofitReady

  11月 2021 - 現在

• Promotional Submissions in eCTD format: Grouped Submissions

  US FDA

  8月 2021 - 現在

• Generic Drug Science and Research Initiatives Public Workshop

  US FDA CDER

  6月 2021 - 現在

• FDA and Health Canada Regional ICH Consultation Webinar

  US FDA CDER

  5月 2021 - 現在

• FDA Study Data Technical Rejection Criteria (TRC): What you need to know.

  US FDA CDER

  5月 2021 - 現在

• ICH Guidelines for Good Clinical Practice

  FMD KL EUROPE

  1月 2020 - 現在

• Labeling and product Information (SmPC, PIL, USPI, CCDS)

  FMD KL EUROPE

  2月 2019 - 現在

• Post Approval Manufacturing Changes

  FMD KL EUROPE

  1月 2019 - 現在

• Drug Master Files (DMF) and Active Drug Master Files (ASMF)

  FMD KL EUROPE

  1月 2019 - 現在

• Specifications and Justification of Specifications

  FMD KL EUROPE

  1月 2019 - 現在

• Good Manufacturing Practices (GMP) for Investigational Products

  FMD KL EUROPE

  1月 2019 - 現在

• CTD Dossier Introduction, types of applications for regulated products

  FMD KL EUROPE

  1月 2019 - 現在

• CMC General Regulatory Topics

  FMD KL EUROPE

  1月 2018 - 現在

• Introduction to Drug Discovery and Development

  FMD KL EUROPE

  1月 2018 - 現在

• Change Management/Change Control

  FMD KL EUROPE

  1月 2018 - 現在

• EU Guidelines for Good Manufacturing Practice for Medicinal Products

  USAID EDMC

  2月 2013 - 現在

• Pharmaceutical Summer School

  USAID CAPS

  7月 2010 - 現在

出版物

WEBSITE

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