His Excellency Dr. Amin Hussain Al Amiri is the Asst. Undersecretary of Public Health Policy & Licensing Sector in UAE Ministry of Health & Prevention
Dr. Al Amiri got his Ph.D. and Ms. C. in Medical Science in 2003 from Faculty of Medicine; Aberdeen University in Scotland; UK.
He is responsible for the following departments at MOHAP:• Drug Dept.
• Empowerment & Health Compliance Dept.
• Organization, Licenses& Advertisement Dept.
• Public Health Policies Dept.
Mrs Nisreen Nassr is an Omani Senior specialist pharmacist, holding a Master degree in pharmaceutical Sciences. Her research was focused on Drug Discovery. In October 2015, she was appointed as the head of registration of Pharma products in the MOH, Oman. She is a member and secretary of the Technical registration and Pricing committee in MOH Oman, Bioequivalence committee and the National committee of Pharmacovigilance. Her responsibilities include policy development regulatory affairs and capacity building.
Prior to this role and since 2002, Mrs. Nisreen handled various tasks as she was the Section of Controlled Medicines, GMP inspector, registration applications reviewer, and handled pricing. In 2007, she effectively contributed in the with WHO/HAI survey on medicines prices availability and affordability.
An experienced professional with in depth knowledge in different regulatory fields related to product regulations that include Medical devices , pharmaceuticals, Biologicals , herbal products, nutritional products, medicated cosmetics and other related product classes (FMCG), A member of multiple technical and policy making teams on a national & regional scale ,most of these teams are joint groups with different authorities from all across the UAE/ GCC like ESMA/HAAD/DHA/ DM / GCC Health Council. Has a wide experience in different areas as regulatory affairs / market access / regulatory compliance and government affairs in the GCC & MENA regions.
Wesal holds a Bachelor of Science in Pharmacy from the University of Jordan, MSc.in Pharmaceutical Sciences from the Applied Science Private University, has completed a professional Diploma in Supply Chain Management. Assigned as Director General Technical Assistant / Jordan Food & Drug Administration in Jan 2021 , and as Drug directorate director from July 2017 until Jan 2021, assigned as Chairman and Vice-Chairman of several committees at JFDA ,She worked as head of drug registration department in the period 2012-2017, through her participation as a member in the Technical Committees, she contributed to the development and establishment of regulations and instructions for drug registration and review process, she was a member in faculty of pharmacy council in several universities in Jordan , she participates regularly in regional and international workshops and conferences (as speaker and trainer).
I hold a PhD in Biochemistry from Imperial College, London and have over 25 years of experience working with biological products in bio-pharmaceutical (CELLTRION, POLUS, ABBVIE), consultancy (PAREXEL), regulatory (MHRA), manufacturing (PROMETIC BIOSCIENCES, LONZA) and academic (ROYAL POSTGRADUATE MEDICAL SCHOOL, IMPERIAL COLLEGE) environments.
In my current role at CELLTRION, I have responsibility for the global regulatory strategy to support our extensive (more than 20) biosimilar monoclonal antibody pipeline. I am presently a member of the Medicines for Europe Biosimilars Sector Group.
At POLUS, I was responsible for the development of an extensive microbial derived biosimilar pipeline with oversight of over 60 scientists and professionals across R&D and regulatory affairs.
At ABBVIE, I was initially part of the Biologic Strategic Development Group, a global team who informed on biosimilar policy and development activities before moving into a European Regulatory Policy and Intelligence role for a variety of other policy areas. Whilst at ABBVIE, I was Chair of IFPMA BioT Working Group and a member of EUROPABIO and EFPIA working groups.
At PAREXEL, I was the European Practice lead for all Regulatory/CMC issues related to biological products, especially biosimilars and predominantly worked with CELLTRION supporting their biosimilar pipeline and the approval of the first monoclonal antibody biosimilar (infliximab, REMSIMATM), in Europe.
At the MHRA, I was a Senior Quality Assessor in the Biologicals Unit reviewing CMC data for all types of biological products and was a Regular contributor to both UK and CHMP scientific advices as well as being a member of various CHMP guideline groups and working parties.
At PROMETIC BIOSCIENCES, I coordinated all Bioprocessing/Technical Support activities relating to affinity chromatography adsorbent development.
At LONZA, my role was a Senior Purification Scientist developing downstream purification processes for monoclonal antibodies for multiple clients and supporting transfer from bench to commercial scale.
Baha AbuSalem is the Program Director of Tatmeen at EVOTEQ. Tameen, an initiative of the Ministry of Health and Prevention, is a highly advanced track and trace platform for pharmaceuticals and medical products based on EVOTEQ’s SmartTrack solution. This program will ensure the protection of public health and improve the security of healthcare at all stages.
A seasoned IT executive, AbuSalem has led large-scale projects in several verticals including government, telecommunications, transportation, and logistics. He has been driving innovation and delivering value-added experiences to companies through new and relevant technologies. AbuSalem holds an MBA from the University of Strathclyde, UK.
Dr.Nasser Alqahtani works for the first Central Health Cluster – Ministry Of Health (MOH) as an executive director for drug and pharmaceutical affairs and acting executive director for population health management directorate.
He is one of the Alfaisal University’s faculty members and works as an adjunct assistant professor of pharmacoepidemiology and Pharmacoeconomics
He used to serve as a director for drug safety and risk management dept at Saudi Food and Drug Authority (SFDA) for 13 consecutive years.
He receives his B.S. in Pharmacy from King Saud University, M.Sc. in clinical pharmacy from the UCL – UK and Ph.D. in pharmaceutical policy and outcomes research (Major: Pharmacoepidemiology) from Auburn University – Alabama, USA. He holds a certificate of higher diploma in pharmacovigilance and pharmacoepidemiology from London School of Hygiene and Tropical Medicine (LSHTM).
He is a member of a couple of professional societies: the International Society for Pharmacoepidemiology (ISPE), International Society of Pharmacovigilance (ISOP) International Society of pharmacoeconomics and outcomes research (ISPOR) American Association of Pharmaceutical Scientists (AAPS). Besides, he is a chairman of the national evidence-based practice committee at Saudi Health Council (SHC)
Sylvie Meillerais started her career in research, in academia and industry, and moved to regulatory policy through positions in Brussels pharmaceutical trade associations, including EFPIA. She then joined MSD as Director Global Regulatory Policy in June 2015; in her current role, her expertise and knowledge of the European pharmaceutical environment serves to drive regulatory policy activities in the areas of CMC and Quality in the EU and globally. She is an active member of the EFPIA Manufacturing and Quality Experts Group and of the Middle East network, where she leads the Life Cycle Management efforts. She is further engaged in IFPMA CMC & Quality policy activities.
Sylvie is a French national and graduated from the University of Bordeaux II with a Maîtrise in Biochemistry and Microbiology in 1993, completed by a Diploma from the University of Kent at Canterbury in the UK (Erasmus programme).
Sylvie can be followed on linkedin.
Frank Dickert started with an apprenticeship in the pharmaceutical industry and afterwards studied biochemistry with a focus on bioinformatics and structural biochemistry.
In 2011 he took an opportunity as a Regulatory Affairs Specialist at a pharmaceutical company and was responsible for centralized, DCP/MRP and national procedures.
In 2017 Frank joined EXTEDO’s Regulatory Competence Center and since then, he is consulting pharmaceutical companies in regulatory business and eCTD submissions worldwide. Furthermore, he is analyzing and optimizing regulatory business processes and document lifecycles with or without software, resolving customer support issues with different eSubmission tools, and offers regulatory consulting with regards to the respective tool.
Qutaiba Al Manaseer, is a Public affairs professional drawing on more than 15 years’ experience in the biopharmaceutical industry. He is the Government Affairs Director for the Middle East and Africa, and he is leading the COVID vaccine supply project in AstraZeneca in this region.
Qutaiba serves in the Emirates Health Economics Society board as the Media and Public Relations Chairman.
Qutaiba holds an MBA from the Swiss Business School, Switzerland and a bachelor’s degree in Pharmacy from the University of Jordan. He is completing a master’s in health economics from Barcelona School of Management.
Before joining AZ, Qutaiba was the strategic market access and pricing lead for GSK Gulf.
Qutaiba is a strong advocate for Diversity and Inclusion, and he was the Global Development Lead in the Executive committee of the Women Leadership Initiative in GSK.
Dina holds a Bachelor of Pharmacy – Faculty of Pharmacy – Cairo university , MBA Maastricht school University-The Netherlands.
She have extensive knowledge and experience in Pharma industry and Health sector, regulatory affairs, governmental affairs for 23 years.
She also spent 10 years working with Ministry of Health in Egypt- Head of registration pharmaceutical, veterinary, Dental medical supply departments and moving to industry working with companies Sevier, MSD.
As a government official, it allows to encounter, deal with lot of different HA, Ministries e.g. ministry of foreign affairs, associations across different countries in ME, Africa. She also was Heading regulatory operations in Egypt, Libya, Saudi Arabia, year 2015- MSD.
In 2016 until date she is heading Gulf region Regulatory operations -MSD Gulf.
She is also the local Chair for the Regulatory Working group in Gulf Region and an active member in Regulatory working group for Pharma Middle East and Africa.
Experienced, dynamic highly successful Regional Head of Market Access and Pricing, with proven ability to develop and execute strategic Market Access plans across wide portfolio of pharmaceutical brands at different stages of product life cycle. Solid expertise in the use of Health Economics in securing Reimbursement and Patient Access to therapy. Demonstrated significant success with major multi-national organizations over the last 13 years; engaging external stakeholders, building KOL networks and shaping Healthcare Policies. Outstanding leadership competencies in managing regional teams, highlighted with strategic thinking, strong analytical and planning skills, combined with the ability to coordinate efforts and influencing cross-functional teams to meet organizational goals.
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. Institute of Technology, USA which upgraded her strategic thinking and enhanced her development.
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.
ENAS I. HASAN
Management, Strategic Planning, Communication, Leadership, Generic Product Development, Formulation Development and Dosage Form Design, Quality by Design, Bioequivalence, Intellectual Property, New Product Selection, Regulatory Affairs, Variations,
Enas I. Hasan
Al-Thuhair-Jordan | 0795779944 | email@example.com
R&D SENIOR MANAGER| HIKMA PHARMACEUTICALS | NOVEMBER 2016 – APRIL 2019
- Led the Formulation development team for Hikma Branded Business for Oral Products (Non- Oncology) in Central R&D Function; more than 20 projects at various stages of development at any time.
- Technology Transfer for centrally developed and outsourced products from Central R&D function to Hikma MENA
- Major participant in the pipeline selection process from the wish list stage, to screening to technical do-ability to pipeline addition.
- Identifying the fastest way for the selected products to be present in the market; with the objective of being first to market more often in Jordan and MENA sites; being well aware of the local requirements in Jordan, KSA, GCC, Algeria, Sudan, Tunis and Morocco
- Due Diligence for outsourced dossiers.
- Prepared R&D budget annually and updated the forecast quarterly.
- Tracked the amount spent per project, and created a system to track the cost of product
- Created a system for responding diligently to any received Deficiency letter from the regulatory authorities.
- Reviewed BE studies quotations and study designs; managed to get approval for all BE studies and Biowaiver requests from JFDA; even in cases of
- Led the Launch team to smoothen the transfer from R&D to operations and to be ready for launch at the time of approval.
- Tracked progress of R&D activities in all Hikma sites.
- R&D Owner for the 5 year Business Plan for Hikma Branded Business in MENA
- Provided summaries on the R&D progress for Upper Management; CEO, CSO and Technical VP
- Reformed the department upon restructuring; and placed a remediation plan for all pipeline
- Managed to close all pending variations and DLs from R&D side in record
- Responsible for the formulation development of the more than 10 products as in house for Hikma, that have either been approved or have been submitted to regulatory review at
- Let the R&D part for Technology Transfer of several originator products into Hikma
- Created a system for transferring the projects to HIKMA sites simultaneously rather than
R&D AND REGULATORY AFFAIRS MANAGER | HAYAT PHARMACEUTICALS | JUNE – OCTOBER 2016
- Led the R&D (AR and PR) and the Regulatory Affairs Departments, in addition to the Technical Manager role for JFDA communication purposes
R&D DEPARTMENT MANAGER | JPM | MARCH 2014 – MAY 2016
- Created a systemized approach to product development, by identifying the development phases and creating a reporting system for each.
- Created the system for product Technology Transfer to the Manufacturing
- Incorporated the concept of Quality by Design (QbD) to product
- Led the team to submit a JPM product to WHO, complying with all requirements, and responded to all received deficiency letters; dossier was
- Created new template for JPM CTD to assure its compatibility with eCTD requirements, introducing as well numerous updates to enrich the technical information presented in the dossier to comply with the evolving regulatory
- Active member of JPM New Products Selection Committee; a committee that is specializing in selecting JPM pipeline products, duties included;
- Targeting possible candidates for development
- Research information related to; manufacturing capabilities, regulatory status, stability, bioequivalence, API and finished product specifications, and primary
- Perform a full IP exercise on candidate products, including patents and data
- Perform patent intelligence investigation to determine patent challenges, possible time of submission/launch in target markets, API form or PSD, formulation technique, potential API suppliers, design around necessities
- Patent searches on Espacenet, WIPO, KACST, GCC and Indian
DEPUTY TECHNICAL DIRECTOR | JPM | APRIL 2012-MAY 2016
- Provided the R&D Department with technical support to assure developed products were in compliance to regulatory, technical and Bioequivalence Starting from dosage form design, small scale experiments, stability and dissolution, review scale up batches, stability results, specifications and other regulatory requirements.
- Handling all JFDA communications in lieu of Technical
- Assisting the Technical Director in a variety of GMP follow
- Following up with the Technical Director the GMP inspections from KSA, JFDA, South Africa and
LICENSING-IN MANAGER, LICENSING DEPARTMENT | JPM | APRIL 2009-MARCH 2014
- Sourcing finished products of interest from partners, and evaluating dossiers and
- Aligning the received dossiers with the JFDA
- Following up of the registration in Jordan Food and Drug Administration (of JPM in- house and licensed products). Assuring their timely registration and response to requirements and deficiency
- Following up and joining the JFDA inspection team to 2 manufacturing plants in
- Following up registration requirements of the licensed products in JPM export
- Preparing Technical agreements with the licensing
- Proceeding as an Active member of JPM New Products Selection Committee; a committee that is specializing in selecting JPM pipeline
- Following up all of JPM’s Bioequivalence studies; initiation, conduct and
- Handling all deficiency letters received by JPM from the regulatory authorities concerning BE
- Compiled and followed the registration of the first Biosimilar Insulin in JFDA, approved as per EMA
- Led the team to the submission and regulatory approval of the JPM licensed products (around 30 products).
GROUP LEADER AND CLINICAL SPECIALIST– R&D | JPM | 2000-2008
- Pre-formulation Studies of active drug substances, including analytical methods development, physicochemical properties, compatibility studies…etc.
- Formulation Development of various pharmaceutical dosage forms, tablets, capsules,
- Pharmaceutical Analyzing of drug substances and pharmaceutical dosage forms using HPLC,
UV/Visible, Automatic and Manual Titration methods. Performing an analysis using and troubleshooting of HPLC, UV/Visible Spectrophotometer, Automatic titrator and Karl Fisher titrator.
- Preparation of Common Technical Document (CTD) Module 3, submitted to the Regulatory Authorities in Jordan and
- Preparation of SOP’s, Working Guidelines and Official documents according to internal
- Analytical method validation
- Evaluating the IP status of different products under Conducting searches, analyzing, categorizing and interpretation of the IP search results.
- Monitoring of Bioequivalence studies conducted for JPM with various Contract Research
- Communicating with various CRO’S, protocol approval, monitoring of clinical and Bio- analytical conduct of BE Studies, Final protocol reviewing and Statistical analyses
RESEARCHER– R&D | JPM | 1997-2000
Patents of Inventions and Data Protection of Pharmaceuticals” a specialized course part of the Arab Certified Intellectual Property Practitioner (ACIPP) Program which was held in cooperation with Talal Abu-Ghazaleh College of Business – German Jordanian University from January 8, 2007 to March 22, 2007.
- Leading lecture in QbD Training for JFDA personnel, organized by JPM, entitled “New Quality Paradigm:
Quality by Design: ICH Q8-Q9-Q10”, Amman, November 2014. n
- Leading lecture in IP and Pharmaceuticals Workshop, organized by JAPM, entitled “Patents”, Amman, July
- The Third Middle East JAPM Bioequivalence Conference, Regulations and Debates, Amman, April 2010. Title of lecture: Overview of the Comments on the Draft EMA Bioequivalence
- The Forth Middle East JAPM Bioequivalence Conference, Amman, April 2011, Title of lecture: International Guidelines on
- 8th Annual Bioavailability/Bioequivalence and Dissolution Testing Conference, Organized by: Informa life sciences, Continental Zara Hotel, Budapest, Hungary, May 2012. Title of Lecture: Achieving Regulatory Compliance for Biowaivers. And the evening Seminar: Case study: Success strategies for obtaining a
- Assessment of controlled release hydrophilic matrix formulation for Metoclopramide European Journal of Pharmaceutics and Biopharmaceutics 55 (2003) 339-344.
- Effect of light and Heat in the stability of Montelukast in solution and in its solid state, Journal of Pharmaceutical and Biomedical Analysis, 2007 Nov 5; 45(3):465-71.
- Member of the JAPM Working Group for
- Member of the JAPM Working Group for
- Participated as an expert in placing the JFDA Bioequivalence and Biowaiver Guidelines in 2009, and in their discussion later on in the JFDA Higher Committee
Samia Kanawati is an experienced and highly respected communications professional in the region, that brings with her more than 15 years diversified experience in Communications, Public Affairs and Regulatory in many therapy areas including rare diseases, HIV, oncology, respiratory, eye care and medical aesthetics among others.
She oversees 40 countries in EEMEA as part of her remit in leading Allergan Aesthetics-an AbbVie company internal and external communications efforts across several practices- including public affairs, social and digital communications, public relations, patient advocacy group relationships as well as crisis communications, dealing with a wide range of stakeholders such as health authorities, medical societies and associations.
What distinguishes Samia Kanawati is her entrepreneurial mindset and dynamic approach not only in her daily tasks but also on a personal level. When she’s not wearing her communicator hat, Samia is passionate about empowering women to play active roles in their communities and loves to join gala events and be part of public awareness initiatives.
Prior to joining Allergan, Samia ran the regulatory and communications functions at Shire Middle East, where she built robust relationships with regional authorities and associations while also advising the company on brand strategies focused on consumer activations. During her tenure she developed a detailed understanding of the legal framework, processes and legislative agendas of regional policy-makers and was influential in communicating Shire’s point of view in the region.
Samia graduated from the University of Jordan with a degree in Pharmacy. She holds an Executive MBA from Bradford University, School of Management in the United Kingdom, as well as a diploma in bio pharmacy from The Martin Luther University of Halle Wittenberg, Germany. She is fluent in English, Arabic and French
Samia’s passion for diversity and inclusion has enabled her to lead the women in leadership initiative, positioning Allergan as ‘Winner of the most Women Friendly Employer Award’ in October 2019 by Naseba Foundation. Her contribution to policy shaping to provide innovative approach enabling early access to medication enabled her to participate with Allergan in launch of UAE Ministry of Health and Prevention innovations’ s strategy hence receiving an “ Appreciation” For Allergan participation in event in January 2019.
Giving back to the community is at the heart of her endeavors. Samia has led a multitude Corporate Social Responsibility campaigns such as World Glaucoma Week, World Primary Immunodeficiency Week, World Hemophilia Day and International Women’s Day in both Allergan 2018 and Shire 2017.
Moreover, she has coveted many awards including the International Powerhouse Award for the Women in Leadership initiative by Allergan, the Best Project Management Award according to Shire and the Silver Award for Partner of Choice to the Business during her tenure at GlaxoSmithKline (GSK).
Bachelor degree in pharmaceutical science and pharmaceutical manufacturing , Head of new medicine registration Unit
She is a member of registration and pricing technical committee, member of GCC medical device committee
Worked on many tasks, worked as registration application reviewer (new, renew and minor variations) , Medical device registered in GCC Council , GMP inspector and pharmacovigilance officer.
Dr Mariam Al-Jalahma was appointed by His majesty the King of Bahrain, in 2015 as the Chief Executive Officer of the National Health Regularity Authority in the Kingdom of Bahrain. She is as a member of the supreme council of health in Bahrain, and is appointed by the prime minister as a member in Academic accreditation Committee of the supreme council for Higher education in 2016.
She was holding the position of Assistant Undersecretary for Primary Care and Public Health until 2015, and was a member of the Executive Board of The Health Ministers’ Council for GCC States until 2016.
A member of the Sura Council in 2000, and a member of the National Institute for Human rights. Dr. Al-Jalahma worked as an advisor for the world health organization in the fields of Adolescents and Non communicable diseases (NCDs).
Qualifications:· Arab Board certificate in Family & Community Medicine in 1990
· Higher studies diploma in medical education from Dundee University in Scotland in 1994
· Diploma in Health Care Management from Royal college of surgeon in Ireland in 2000
Honorees & medals
· In December 2011 she was awarded an honouree medal of efficiency by his majesty the king of Bahrain.
· In 1990 Awarded by the prime minister awards for leaders of Moharraq.
· In 2009 she was awarded by Her Highness Shaikha Sabika Bent Ebrahim Al-Khalifa the Princess of Bahrain and Chairperson of Woman Supreme council the award of National Woman day Celebration, the award is presented to women leaders in health.
· In June 2011 she is awarded by the regional office for eastern Mediterranean of the WHO the Anti-tobacco award of the region.
· Global award for health pioneers from UAE
· GCC leaders Award 2019
13 years experienced pharmacist with a diversified expertise and a high exposure to the medical registration and regulatory issues as well as deep understanding of the registration requirements and procedures of the MENA Ministries of Health.
Regulatory Affairs & Pharmacovigilance Manager- MENAT- Aspen HealthCare –Dubai -UAE Dec 2020 – Present
- Lead and influence regulatory interpretation, product labelling, implementation of compliance strategies, as well as projects leadership, employee supervision, training and Drive optimization effectiveness of internal processes/procedures and best practices.
- Provide regulatory guidance to compiling/reviewing new product registration and variation dossiers for submission to the relevant regulatory agencies.
- Identify regulatory projects requirements and scope of work and develop project
- Precisely communicate regulatory information to multiple departments and ensure that information is interpreted
- Interacts with internal and/or external stakeholders/clients. Identifies and responds appropriately to issues, providing adequate solutions.
- Review all submission application to regulatory agencies across MENA ensuring timeliness are met, accuracy, comprehensiveness, or compliance with regulatory
- Ensure that the team keep abreast of current data, trends, regulatory knowledge, developments and advances in the regulatory environment.
- Ensuring regulatory team professional development, performance appraisals and employee counselling/mentoring needs are met
- Assimilate regulatory requirements by coordinating projects involving new products, markets, systems and strategies and reviewing, updating, archiving and publishing policies, standards and
- Work cross functionally on new products launches and products acquisition with the new business development and commercial
- Support with all Pharmacovigilance activities with regards to Good Pharmacovigilance Practices (GVP) in alignment with the strategy defined by the business and Aspen Healthcare
- Manage the generation of PV Master Files according to each market requirements on MENA level
- Manage the submission of serious adverse reaction reports, PSURs and Post-authorization Safety Study (PASS) in cooperation with MAHs and reports to Ministry of health as
- Mange the implementation of Global and local SOP’s and how to respond to requests for information from regulatory authorities
- Manage Local reporting and communication with Company EU QPPV (APTL) and cooperate compliance
- Manage Local reconciliation Adverse and serious drug reactions on MENA level with the Marketing Authorization
- Manage the necessary local literature review on MENA level with
- Manage the necessary process to generate, update and finalize SDEA agreements with
- Train Staff to perform Pharmacovigilance related activities. This includes not only staff within the Pharmacovigilance units but also staff who may receive or process safety reports, such as sales personnel, distributors,..etc. Provide a brief description of the training system and indicate where the training records, Curricula Vitae (CVs) and job
- Internal Audit for currently signed SDEA with
Senior Regulatory Affairs & Labelling Associate MENAT- Aspen HealthCare –Dubai -UAE May 2017 – Dec 2020
- Work with market regulatory lead to develop a detailed understanding of regulatory guidelines and technical requirements in assigned countries.
- Files compilation and follow up on the submitted
- Meet the planned submissions dates and ensure continuity of the
- Feed the trackers with accurate information and ensure regular
- Coordinate and prepare renewal of regulatory certificates/ post approval
- Ensure that locally prepared submission packages go through the required quality control check (QC) to ensure they are formatted properly and contain all required elements to meet local regulatory and scientific / technical
- Act as a link between the global organization and the regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate local
- Ensure a proper archiving for any submitted
- Provide assessment/ input for the regulatory projects rolled out by different Aspen
- Work on assigned projects to assist other affiliate where needed based on the business
- Promotional materials review/approval and coordination with marketing and medical
- Act as the MENA superuser of Aspen’s AW management system;
- Gather specifications needed for the execution of packaging
- Supervise the full life- cycle of packaging artwork creation and
- Work closely with other teams and stakeholders to coordinate the whole process from concept/creation to artwork release.
- Mockups creation to support various types of submissions and production Artwork creation post Health authority’s approval (either on Pulse or with 3rd party partners).
- AW Quality control ensuring the proper revision and editing of English content as well as the Arabic translation to have robust
- Provide the affiliates across MENA with the necessary support with regards to artworks creation/ modification where
- Plan for the appropriate timelines of receiving and dispatching all requested
- Coordinate and follow up during product review till approvals of all ongoing projects are
- Create and maintain a shared tracker for all the ongoing changes for the
Regulatory Affairs Officer ME- Pfizer Consumer Healthcare – Dubai- UAE September 2015 – April 2017
Responsible for the full renewals and variations processes and support new registrations of Pfizer Consumer Healthcare products in the ME markets, including the submission of all the governmental requirements & studies according to the guidelines of the Gulf and Levant Markets, covering all aspects technical, administrative& legal processes.
- Development of registration plan for products/markets including local requirements and expected approval
- Provides inputs of anticipated market specific regulatory issues for planned submission inputs/feedback into MENA registration plan for new
- CTD/e-CTD files and market-specific file compilation including preparation of market-specific documents g. application forms, summary sheets and clarification letters.
- Follow-up with the regulatory authority during submission review and ensure all questions /requests are provided/clarified within due time to ensure timely approval of
- Ensure that all marketed products in the country are in compliance with local and corporate regulatory requirements, e. labelling (Product Information and packaging development); label change management; chemistry and manufacturing commitments that were registered with the MOH.
- Ensure local label creation will meet local and corporate criteria by providing the necessary
- Tracking of regulatory
- Ensure that manufacturing sites & MAH are registered in markets that require site
- Archive and maintain records according to local, global SOP’s.
Senior Regulatory Affairs Coordinator – UGP (Hospira-a Pfizer company- Agent in Egypt) March 2011 – May 2014
- Ensure submitted product documents will fully meet the local regulatory requirements of CAPA – Egypt for imported finished products.
- Achieve products registration and pricing for new products as per agreed
- Act as first point of contact with regulatory
- Maintain regular contact/relationship with key regulatory officials
- Maintain contact and liaise with key business partners, internally and
- Set up, maintain and update the pharmacovigilance system including collecting, evaluating and report information of adverse reactions/medicinal product risks, and coordination of the necessary
- Establish and maintain the Market Authorization Holder’s (MAH) Pharmacovigilance System.
- Ensure the timely response of Egyptian Pharmacovigilance Center requests of any information required for the evaluation of the benefits.
- Act as a single point of contact for Egypt’s regulatory authority on a 24-hour basis and provide the contact point for pharmacovigilance
Regulatory Affairs Specialist – Jedco International Pharmaceuticals Co. – Cairo-Egypt March 2010 – March 2011
- Submission of product documents to meet the local products registration requirements of CAPA (Central administration for Pharmaceutical Affairs)-Egypt.
- Maintain contact and liaise with regulation authority to continuously monitor and update the product’s status under
All technical procedures of locally manufactured drugs registration and submission of different required studies according to the guidelines of the Egyptian Health authority.
Quality Control Analyst – Jedco International Pharmaceuticals Co. –Cairo-Egypt July 2008 –March 2010
- Raw material C
- Packaging material C.
- Finished Product C
- Microbiology C
Community pharmacist – Dr. Raaid Mohammad pharmacy – Cairo- Egypt July 2007- July 2008
- Bachelor of Pharmaceutical Sciences – [Ain Shams University] – 2007
Grade: Very Good with Honour
Personal and other skills:
- Analytical thinking that leads to smart
- Able to work in a flexible team
- Able to communicate to various levels of understandings ensuring that clear messages are delivered both verbally and
- Problems solving and goals achieving
- Continuous learning and acquiring of new skills either professional or
- Arabic: Native Speaker
- English: Fluent
- French: Intermediate-advanced
- Microsoft office (MS Excel, MS Word & MS Power Point)
- Internet & e-mail
References are available upon your respectable request.
Regulatory Affairs expert with a demonstrated history of working in the Pharmaceutical industry. Played different roles in Middle East region strongly focusing on pharma, consumer health, OTC, nutrition & medical devices. Leading teams in cross-functional projects directly impacting expansion and access of new innovative medicines. Lead task forces in Pharma associations opening dialogue with MOH enforcing regulations. Speaker in Pharma-industry conferences.
Areas of expertise
Extensive experience in portfolio management of different classifications such as OTC & Prescription medicine, Medical devices, Nutrition and cosmetics, and Biological products. Leading as a business partner to identify future trends and tailoring best regulatory solutions. Liaise with supply team to secure stocks and pre-solve coming challenges.
Bring 15 years’ experience in pharmaceutical industry in national and multinational Companies in Egypt and extended to middle east including Sanofi and Bayer. Joined IQVIA as associate director Global Regulatory Affairs.
Bachelor’s degree in Pharmaceutical science from Cairo university in Egypt,2005.
Diploma in Marketing from the American university in Cairo, 2010.
Sattam Turky Alghodyyr began his career as a pharmacist at King Khalid Hospital, AlMajma’ah, but soon moved to the Saudi Food & Drug Authority gaining unparalleled experience in the Bioequivalence, while also establishing himself as an expert in Pharmacovigilance.
In 2016 he started at Saudi Pharmaceutical Industries and Medical Appliances Corporation- SPIMACO as the Pharmacovigilance and Bioequivalence Manager where he is now Director of Regulatory Affairs.
Sattam is the Founding Member of the Pharmaceutical Industry Association PIA, Member of the Board of Directors ARAC Healthcare Oct 2018 and a Committee member representing SPIMACO on the National Committee for Pharmaceutical Industries NCPI.