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Wednesday, 20 April 2016

Reem Khayal, Regulatory Affairs Specialist at Hikma Pharmaceuticals

Reem Khayal

Reem Khayal

Regulatory Affairs Specialist at Hikma Pharmaceuticals
LINKS
e-mail is: reem.m.khayal@gmail.com
My phone number is: Dubai: + 971551864126
https://jo.linkedin.com/in/reem-khayal-a3228430
https://www.researchgate.net/profile/Reem_Khayal/info
https://www.facebook.com/reem.khayal.3/about
https://twitter.com/rkhayal
 https://in.pinterest.com/reemkhayal/
 http://people.bayt.com/reem-khayal/

Summary

Being passionate and highly motivated pharmacist holding a master degree in Pharmaceutical Technology, 8 years of experience in Pharmaceutical Industry, having exceptional communication skills with individuals, teams and regulatory agencies, I have proven to be a knowledgeable and effective employee to make a positive contribution in the organizations I have worked /working with.
Achievements:
• Participated in the preparation of an U.S. FDA inspection in April 2012
• I have prepared many ANDAs using Common Technical Documents (CTD) and electronic Common Technical Documents (eCTD) guidance
• I have received approvals for many supplements submitted with sufficient information to save time and efforts
• I have been promoted to supervise a local Regulatory team in the United States of America.
• I have been nominated as the Employee of the month in June 2013

Experience


Regulatory Affairs Specialist

Hikma Pharmaceuticals
– Present (1 year 10 months)Amman - Jordan
• Implement and execute on goals, strategies and policies developed by Executive Team
• Execute and maintain regulatory activities for both new and approved drugs including filings, labeling, advertising and promotional review
• Monitor and ensure compliance with regulatory expectations of the U.S. FDA regarding quality and timing of submissions
• Review, finalize and approve all regulatory fillings prepared by local U.S. Regulatory Teams for both new and approved drugs
• Handling the preparation and maintenance of regulatory affairs database
• Supervising the takeover of all acquired existing NDA/ANDA documentation as per U.S. FDA expectations
• Prepare periodic reports with respect to the function’s activities and achievements related to US market
(Open)1 course

Regulatory affairs officer and team leader

Hikma Pharmaceuticals
(3 years 1 month)Amman - Jordan
• Preparation and submission of ANDA, Amendments (Bioequivalence amendments, CMC amendments, Labeling amendments…etc.), supplements (Prior approval supplements, CBE-30 Days Supplement and CBE-0 Day Supplement) and Annual reports
• Communication with the regulatory agency
• Evaluation of Any changes for the approved and pending products
• Review and approve the test methods, specifications, stability and packaging standard for raw materials, in-process materials and finished product materials of the ANDA
• Initiation or revising the labeling materials (inserts, medication guide, bulk labels and container labels)
• Keep updated with the latest changes of the guidelines
• Drug listing for U.S. products
• Follow up with all batches placed into stability and validated because of the regulatory requirements
• Undertaking and managing regulatory inspection
• Advising and dealing with any related questions or complaint regarding the regulatory requirements
(Open)8 courses

Formulator and Analyst

Tabuk Pharmaceutical MFG Co
(4 years 1 month)Amman - Jordan
• Professional using and Calibration of HPLC(Shimadzu, Dionex & Thermo TSB), UV spectrophotometer, Dissolution, Karl Fischer and Differential scanning Calorimetry (DSC) instruments
• Applying and using different Pharmacopoeias (USP, BP and EP)
• Analysis of raw materials and Finished products samples
• Develop and validate methods of analysis
• Conducts literature search for the projects including publications, patents, etc.
• Designs and conducts pre-formulation, formulation development and scale-up manufacturing on assigned projects
• Conduct stability studies
(Open)2 courses

Publications


Solid dispersions of Ezetimibe with improved dissolution rate and physical stability(Link)

AAPS annual meeting and exposition, Washington DC, USA.

The Purpose was to prepare a physically-stable, solid dispersions (SD) of Ezetimibe (EZ), a poorly water-soluble class II drug using polyvinylpyrollidone (PVP) K30, in an attempt to improve its in vitro dissolution profile.
Methods.
amorphous EZ was prepared by different methods, which served as a reference. SD of EZ with different ratios of PVP K30 (5-80%) were prepared using spray drying. SD...more

Courses

Hikma Pharmaceuticals

  • Training workshop for Hikma RA teams
  • Labeling comparison Programme (Docuu-Proof)
  • Basic Regulatory Principles of Commissioning and Qulaification in Pharmaceutical Industry
  • cGMP training
  • Quality by Design & Quality Risk Management in Pharmaceutical Development and Manufacturing
  • Empowered Leadership Program
  • Time and Stress Management
  • First MENA Conference for Regulatory of Bioequivalence, Biowaiver, Bioanalysis and Dissolution

Tabuk Pharmaceutical MFG Co

  • Customer seminar for Differential scanning calorimetry and Thermogravimetric Analysis - Switzerland
  • Strategies For Time Management Excellence

Hikma Pharmaceuticals

  • Emotional Intelligence

Education









Jordan’s King Abdallah opens Hikma’s oncology API plant

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