Reem Khayal
Regulatory Affairs Specialist at Hikma Pharmaceuticals
e-mail is: reem.m.khayal@gmail.com
My phone number is: Dubai: + 971551864126
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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
• 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
• 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
•
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
• 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
•
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
• 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
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
Jordan University of Sceince and Technology
- Marketing effectiveness
Hikma Pharmaceuticals
- Emotional Intelligence
Education
Jordan University of Science and Technology
Master, phamacetical Technology
Activities and Societies: Research Topic: Stability and Solubility of Amorphous Ezetimibe in solid Dispersions. During my search, which was a collaborative work between Just University in Jordan and Lulea University in Sweden, I was able to experience different instruments which include Differential scanning Calorimetry, Powder X-Ray Diffraction and Fourier Transform-Infrared Spectroscopy
Jordan’s King Abdallah opens Hikma’s oncology API plant
King
Abdallah of Jordan on Tuesday stressed the important role of investors
and businessmen in supporting the country’s economy and providing
solutions to mitigate the problems of poverty and unemployment.
During a visit to Hikma Pharmaceuticals, the king stressed the importance of focusing on developing the capabilities of the national economy in the coming stage through investment projects where the private sector can play a major role.
The king inaugurated Hikma Pharmaceuticals’ chemical plant for oncology active pharmaceutical ingredients (API) specialized in producing effective raw materials for cancer medications. He underscored the company’s role in providing thousands of job opportunities for qualified Jordanians. He highlighted the contributions Hikma made to the economy and the labor market across the Kingdom at all its manufacturing sites.
Accompanied by ministers and other prime dignitaries, the king listened to a short review about Hikma Pharmaceuticals by Mazen Darwazah, CEO and president of MENA and emerging markets at Hikma Pharmaceuticals. The King was given a tour of the new plant and briefed by Dr. Yusuf Al-Khayyat, director general of the new plant, on its goals mainly providing a sustainable source of the vital ingredients needed for cancer medications in Jordan in particular and MENA countries in general.
Darwazah said: “36 years ago, Hikma Pharmaceuticals started manufacturing pharmaceutical products as a local emerging industry fulfilling part of the national pharmaceutical market’s needs. Today, it’s a Jordanian company marketing its products worldwide, owning 27 manufacturing facilities in 11 countries, contributing to over 7 percent of the national exports and holding a 12 percent share in the Jordanian Pharmaceutical Market. We take pride in Hikma’s accomplishments; we recognize that this success would not have been achieved without the supportive environment and capabilities offered by our precious country under the Hashemite leadership. The king’s honorable presence is a motivation for the Hikma family to grow, working confidently toward a better future.”
Hikma has become the first company to establish a world class oncology API plant in the MENA region. This latest expansion finalizes the production cycle of oncology products.
Designed with state-of-the-art technology (isolators technology) to comply with local and global registration requirements, the Oncology API plant is a significant frontward integration that will add great value to the manufacturing capabilities of the of the company and will reduce Hikma’s dependency on external parties.
Hikma is committed to providing high quality medication to cancer patients worldwide and especially in Jordan. Hikma has invested a lot in developing capabilities for the manufacturing of oncology products; these investments include the acquisition of Thymoorgan in Germany, joint venture with Haosun in China and the recent establishment of the oncology line in the chemicals plant in Jordan.
During a visit to Hikma Pharmaceuticals, the king stressed the importance of focusing on developing the capabilities of the national economy in the coming stage through investment projects where the private sector can play a major role.
The king inaugurated Hikma Pharmaceuticals’ chemical plant for oncology active pharmaceutical ingredients (API) specialized in producing effective raw materials for cancer medications. He underscored the company’s role in providing thousands of job opportunities for qualified Jordanians. He highlighted the contributions Hikma made to the economy and the labor market across the Kingdom at all its manufacturing sites.
Accompanied by ministers and other prime dignitaries, the king listened to a short review about Hikma Pharmaceuticals by Mazen Darwazah, CEO and president of MENA and emerging markets at Hikma Pharmaceuticals. The King was given a tour of the new plant and briefed by Dr. Yusuf Al-Khayyat, director general of the new plant, on its goals mainly providing a sustainable source of the vital ingredients needed for cancer medications in Jordan in particular and MENA countries in general.
Darwazah said: “36 years ago, Hikma Pharmaceuticals started manufacturing pharmaceutical products as a local emerging industry fulfilling part of the national pharmaceutical market’s needs. Today, it’s a Jordanian company marketing its products worldwide, owning 27 manufacturing facilities in 11 countries, contributing to over 7 percent of the national exports and holding a 12 percent share in the Jordanian Pharmaceutical Market. We take pride in Hikma’s accomplishments; we recognize that this success would not have been achieved without the supportive environment and capabilities offered by our precious country under the Hashemite leadership. The king’s honorable presence is a motivation for the Hikma family to grow, working confidently toward a better future.”
Hikma has become the first company to establish a world class oncology API plant in the MENA region. This latest expansion finalizes the production cycle of oncology products.
Designed with state-of-the-art technology (isolators technology) to comply with local and global registration requirements, the Oncology API plant is a significant frontward integration that will add great value to the manufacturing capabilities of the of the company and will reduce Hikma’s dependency on external parties.
Hikma is committed to providing high quality medication to cancer patients worldwide and especially in Jordan. Hikma has invested a lot in developing capabilities for the manufacturing of oncology products; these investments include the acquisition of Thymoorgan in Germany, joint venture with Haosun in China and the recent establishment of the oncology line in the chemicals plant in Jordan.
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