The GCC Quality Conference 2023, is focused on the Commercial Quality Perspective and is the First Gathering Point for Commercial Quality Professionals in the GCC.
Regardless of the business, quality, is one of the most crucial management concepts for every firm. This is especially true for the pharmaceutical industry, where upholding high product standards is crucial for the treatment and prevention of a wide range of diseases.
Despite the fact that the pharmaceutical business has been operating for millennia, more pharmaceuticals have recently been introduced to the market. The demand for quality assurance and quality control procedures in the commercial state has increased as a result of this development.
Pharma QA and quality assurance departments are the backbones of the pharmaceutical business. They allow companies to guarantee that their products conform to applicable quality, drug stability and safety standards. In addition, they ensure that a company avoids non-compliance of regulatory requirements.
Marriott Al Jaddaf Hotel – Dubai, UAE
10th March 2023
10+ Speakers
100 Seats
The GCC Quality Conference 2023, which is the first meeting place for commercial quality professionals in the GCC, will be focused this year on the commercial quality perspective.
Ahmed is a pharmaceutical industry professional with over 10 years of experience in regulatory health authority engagement, pharmaceutical product licensing and lifecycle maintenance, market access/reimbursement, good pharmaceutical manufacturing, distribution, and quality management.
He started his career with GSK in 2011 and moved to Roche in 2020. He has been a standing representative on the Regulatory Affairs Working Group (PHRMAG) since 2015 and has been leading UAE policy advocacy efforts on behalf of the group since 2021.
He is a licensed pharmacist and a published academic. He holds a Bachelor of Science in Pharmaceutical Sciences and Biotechnology from the German University in Cairo.
Nawel Boukhatem has over 14 years experience within the pharmaceutical industry in regulatory Affairs across 4 different regions Middle East-Maghreb, Egypt & south Africa & North Africa. Nawel is currently the Head of Regulatory Affairs for Middle East region and sitting in strategic discussion within ICMEA (India -Middle East-Maghreb, Egypt & south Africa, UCC & Turkey) in Takeda pharmaceuticals Company Limited (TSE:4502/NYSE:TAK) a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI).
Before joining Takeda Pharmaceuticals company, Nawel was Regulatory Affairs Associate Director at Shire pharmaceuticals for MEA before Takeda acquisition of Shire .
Prior Shire Nawal was regulatory affairs at Baxter pharmaceuticals for 3 years.
Ebla Khadra has over 12 years’ experience within the pharmaceutical industry in Regulatory Affairs across different regions GCC, Lebanon, and several countries in the continent of Africa. Ebla is currently the Regulatory Affairs Specialist for Middle East region in Takeda pharmaceuticals a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, PDT Immunology, Gastroenterology and in some markets Neuroscience and Vaccines.
Before joining Takeda Pharmaceuticals, Ebla was Regulatory Affairs consultant at Shire pharmaceuticals for Middle East appointed by PRA before Takeda acquisition of Shire.
Prior Shire Ebla was regulatory affairs in her home country (Syria) for over 7 years and her major achievements have been:
He is the Chief Quality and Product Officer at Scigeniq.
Scigeniq is a unique provider of expertise and software solutions for life sciences companies with major focus on Pharma. We bring tremendous experience and expertise to our customers, guiding their modernization and transformation journeys with an integrated combination of advisory services and world-class software solutions. Our product suite includes DMS, QMS, RIMS, EBR and LIMS.
Abdullah is technically experienced in the Pharmaceutical industry (+20 years) comprising Quality and R&D. Certified Auditor and QA manger by APIC.
Abdullah worked as Quality Compliance Executive Director at Axantia leading the Quality and Compliance Management.
Before that was Corporate Quality and Compliance Senior manager for Hikma group conducting Quality audits on Hikma suppliers/ contract manufacturers, CROs and Hikma subsidiaries focusing on sterile manufacturing.
Conducted more than 70 internal and external Quality audits according EU GMP and US FDA in different countries like Europe, India, Taiwan, Japan, Middle East/North Africa and USA.
Managed many Technology Transfer Projects having the current FDA, EMA and ICH requirements and Quality standards.
Experienced in Pharma Digitalization transformation including electronic Quality Management Systems (eQMS), Regularity Management System (RMS), Laboratory Management System (LIMS), Document and Training Management Systems( DMS& TMS), Calibration and Maintenance Systems ( Asset management)
Holds an MSc in Pharmaceutical Analysis encompassing Pharmaceutical solid forms characterization from the University of Durham, UK.
Dr. Yousra a Regulatory Affairs and Commercial & Distribution Quality Assurance Director, Strategic Project Lead with over 17 years of diversified experience from various leadership positions in Regulatory Affairs, Quality Assurance within Health Authority as well as multinational organizations at both regional and local levels.
Dr. Yousra is currently leading Abbott-Gulf & Emerging Markets Regulatory Affairs, Quality Assurance and Strategic Projects. In her role in Abbott Established Pharmaceutical Division; Yousra is responsible for setting Regulatory Strategies for New Product Introduction, Geo-expansion, Licensing & Acquisition, Localization, Life cycle management, enhancement of promotional model, as well as RA risk mitigation and regulatory compliance.
Dr. Yousra has set effective regulatory strategies of external engagement including Health authorities, local distributors, trade associations and Third-Party Manufacturers. This is in addition to her Quality Assurance responsibilities of establishing and embedding Quality Management System within GEM.
On top of that, she set the base for strategic projects within the Gulf & Emerging Markets and lead the execution of a variety of initiatives that support patient centricity.
Dr. Yousra is holding a bachelor of pharmaceutical sciences from Cairo University and RAPS-DPC certification/USA-UAE and She has also completed the “New Leadership Program (NLP)”, by Harvard Business School and is currently enrolled in “Professional Diploma in Business Planning and Strategy”, by Rochester Institute of Technology, USA.
Mohamed Hayani Quality Assurance Manager handling the MENA region at NewBridge, has over 20 years of experience within the pharmaceuticals industry manufacturing facilities and commercial operations.
Quality Assurance professional with progressive experience with market-leading multinationals in pharmaceutical worked with senior leadership teams at regional on strategic initiatives aimed to grow and reshape businesses, I have successfully increased efficiency and productivity while reducing cost.
Mohamed Hayani is a holder of a bachelor’s degree in Applied Chemistry from Aleppo University, and holder of a CMQ certificate at ASQ (American Society for Quality).
Gert-Jan moved t3o his current role in AbbVie Global Security in August 2021. Managing Supply Chain Security for Europe, Middle East, and Africa region, for both AbbVie and Allergan Aesthetics. Located at AbbVie Logistics (VLOG) in Zwolle, The Netherlands and member of the VLOG Crisis Action Team.
In this Supply Chain Security role Gert-Jan is responsible for Transportation Security and Distribution Center Facility Security, including Supply Chain Business Continuity Planning and Crisis Management, with oversight to all 3PL warehouses and distributor wholesalers in the EMEA region.
Within Global Product Protection, Gert-Jan is responsible for Product Security and Traceability, Internet Monitoring, Product Security Incident management, and Anti-Counterfeit training for EMEA.
Gert-Jan joined AbbVie in January 2014 as QA Program Manager within the global Supply Chain Compliance team focusing on Traceability and Serialization, Supply Chain Security, Supply Chain Visibility, and Medical Device Life-Cycle Management.
Gert-Jan has been QA Program Lead for implementing the EU Safety Features (EU FMD program) and is member of the EFPIA Supply Chain working group.
As per March 2009 Gert-Jan became member of the PDA PCCIG EU Branch Steering Committee and has co-authored the article Pharmaceutical Supply Chain Security Risk Assessment for Shipping Lanes (Pharmaceutical Outsourcing, Sept. 2017).
Prior to AbbVie, Gert-Jan joined Abbott in January 2007 supporting the global Cold Chain Management program. With 5 years of experience in food logistics and retail in previous roles, he became subject matter expert for Good Distribution Practices (GDP) compliance in the pharmaceutical industry.
Gert-Jan holds a bachelor’s degree in Business Economics and Logistics at the HES Amsterdam.
Global Strategic Compliance Quality Director with over 22 years of diversified Quality experiences in the scope of Technical Ops, Manufacturing, Commercial affiliates and Distribution within the Pharmaceutical and Medical Device industry including over 12 years in Quality leadership position within a multinational business culture.
His experience covers various type of operations, Sterile (liquid, lyophilized), non-sterile (solids, semi-solids and liquids) and Beta lactam/Cephalosporins including deployment of operational excellence utilizing practical knowledge and expertise to integrate lean manufacturing principles (kaizen tools) within a regulated environment delivering tangible results in process optimization, reducing product defect rate and achieving product cost avoidance.
Experience was acquired globally in North America, Middle East, Africa, and China. Mr. Mazen is a collaborative leadership team member and recognized change agent with critical thinking and problem solving as strengths which resulted in leading quality issue mitigation for sustained improvement and deploying the expected Quality culture. He has a track record for effective collaboration with cross-functional teams to attain and sustain robust and fit for purpose compliant operational QMS across different business processes and new acquisitions in accordance to USFDA, Health Canada and GCC regulations yielded outstanding inspection’s outcome.
Further, engaged in projects for new products launch, geo-expansion, technology transfer and Supply Chain projects transition to outsourcing operations in the USA and China effectively. Currently, he am a collaborative member of the global quality leadership team responsible for defining and enhancing the company’s Quality strategy map, strategic projects and monitoring programs.
Driving globally strategic Quality compliance concepts by partnering with cross functional teams to define tactical approaches, guidance and best practices to arm process owner for effective implementation of critical operational and quality processes such as Pharma 4.0, CPV/OPV, GxP data integrity, etc.
Passionate Quality professional with more than 15 years’ experience in different industries pharmaceutical, FMCG, cosmetics, across global geographies/cultures/ standards and different regulations.
Maya has collaborated throughout her career with famous multi-national companies and organizations including Gsk , UCB, reckitt, L’oreal in Europe, ME, Africa and India
Wide quality background: managing end to end quality from operational/manufacturing to commercial and supply chain quality for diverse categories of products (non-sterile: oral solution, tabs, hard capsules, Oral drops, syrup, Nasal spray solution -Sterile: suspensions, cytotoxic freeze dry products, syringes, vials, ampoules, and Cosmetics & hygiene/home products)
She holds a master’s degree in biochemistry and industrial engineering degree specialized in quality management.
Her passion is in helping individuals and companies to drive, enhance & develop the areas relating to Quality Management, sustain robust and fit for purpose compliant operational QMS across different business processes and successfully to institute effective positive change in culture for an effective collaborative teamwork and result.
Enthusiast about diversity and inclusion and health & mental wellbeing
By attending the GCC Quality Conference, you will be able to have a broad range of understanding about the quality measures that you need to be aware of in the pharma industry, learn about quality procedures and their updates from governmental entities and industry professionals, as well as network and share your expertise.
Join the GCC Quality Conference to grasp the understanding of the requirements and procedures required for you to become aware on how to process and manage your quality department at your organization, and how to excel in Pharma’s quality.
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