Pharmaceutical Regulatory Affairs & Compliance Expert

GAMAL ABU-AMER - CV *

Gamal Kamel Abu-Amer

I’m a pharmaceutical industry expert, specializing in the establishment of Regulatory Affairs & Compliance services for medicinal products (all legal categories) as well as Medical Devices (all Class).

My experience includes regional regulatory project strategy, execution, team leader, direction and development with sufficient experience on pack management. I have further experience around pharmaceuticals warehousing & supply chain; Governmental Affairs, Pricing and Business Development to allow a channel for products that would otherwise not achieve their full potential, within the Gulf and Near East Region.

Career History

August 2011 to June 2023 (12 Years Slaving at GSK) GlaxoSmithKline (GSK), Dubai, UAE

Regulatory Affairs Manager, Regulatory Project Leader & Pharmacist In-Charge of MultiMarkets Warehouse (MMW) Hubs; for Gulf & Near East Markets:

– Responsible to obtain Marketing Authorisation Application (MAA) approval on time to enable the organization to achieve their objectives across the cluster of Gulf Growth Markets & Middle East Performance Markets covering 14 markets: Bahrain, Kuwait, Oman, Qatar, UAE; Afghanistan, Bangladesh, Iraq, Jordan, Lebanon, Libya, North Sudan, Syria and Yemen).

– Acting as Strategic Partner with a Central Regulatory Project Strategy Lead;

– Key Regulatory Affairs point of contact for Intelligence on all Regulatory Project;

– Liaising with internal and external clients/stakeholders in the provision of the Service; – Building up strong relationships with all stakeholders & regulatory affairs contacts at the local distributors, and Local Competent Authorities;

– Dossiers solution of all regulatory affairs submissions (First registration, variations, renewals, Response To Query and Manufacturing Sites;

- Developing regulatory strategies to resolve obstacles in order to achieve right first time

& smooth submission and fast approval;

– Contributing in pack management needed for market specific pack requirements. GAMAL ABU-AMER - CV 2

– Contributing in Pharmacovigilance management system and being key point of contact between Central and local competent authorities;

– Contributing in different measures & systems protecting the company, e.g. Quality Management System (QMS), Risk Management System (RMS), Standard Operating Procedure (SOP), Product Incident Recall Committee (PIRC), Local Product Incident Recall Committee (LIRC); Dear Healthcare Professionals’ Letter (DHCPL)

– Contributing in efforts to apply methods and practices to optimize the newly assigned regulatory team;

– Applying related regulatory compliances and identifying potential risks and update all relevant stakeholders;

– Creation of database for local legislations/regulations, licensed products & their Mfg. Sites and on-going applications (Tracker).

– Leading the regional project of Assessment on the Set-up & Capability of the Regulatory Affairs function of the Local Distributors in order to meet “GSK” expectation & standard of third-party business partner; and to suggest improvements to the current ways of work; and collaborate on relevant actions plans as appropriate. – Consultation and dossier solution to enable Line Management of New Product Introduction to achieve their objective by obtaining Marketing Authorization Approval on timely manner.

– Pharmacist In-charge for Multi-Market Warehouse (MMW) in Free Zone-Dubai.

- Represents GSK with professional pharmacist license at MoH-UAE to allow pharmaceutical operation in MMW.

- Manage the operating pharmaceutical licenses and practices for GSK Multi Markets Warehouse HUB in compliance with local health authorities’ regulations and standards for Good Storage Practices and Good Distribution Practices.

- Supervision and ensuring compliance of Third-Party Storage & Distribution.

– Enabling Supply chain management and government tender management to achieve their objective by providing regulatory support for successful approach with the local health authorities for exceptional approval in order to avoid supply constraint.

– Enabling Business management to achieve their objective by providing regulatory support for selected strategic projects (Divestment/Licenses transfer, localisation, Harmonisation, SLA etc.).

Achievements:

• 2011 – Licenses Transfer of all of Stiefel’s products from Stiefel to GSK on time.

• 2012 – Restate of supply of all Stiefel Products further to resolving the crisis of compliance due to CMC gabs.

• 2014 – Licenses Transfer of Stiefel Consumer Products from GSK-Pharma to GSKConsumer Health (Now is Haleon).

• 2014 – Partial MAH transfer of Thrombosis2014 – products from GSK to Aspen (Invoicing by Aspen without waiting full MAH transfer).

• 2015 – Licenses Transfer of thrombosis products from GSK to Aspen on time.

• 2016 – Assessment/Development of Third-Party Regulatory Affairs Services Provider

(Local Distributors).

• 2016 – Harmonisation of distribution agreements to include Regulatory Services Level Agreement (SLA).

• 2016 – Re-export of expired Controlled Products for destruction purpose outside UAE. GAMAL ABU-AMER - CV 3

• 2016 – Obtaining authorisation permits for controlled products within 5 working days instead of 30 working days.

• 2017 – Assessment of 3rd Party Warehouse Service Provider in Jebel Ali Free Zone.

• 2017 – First registration of bOPV (Bivalent Oral Polio Vaccine) in Jordan and securing its related tender business (2017).

• 2018 – Protecting GSK from a disciplinary action by MOH-UAE further to wrong supply of a controlled Product (Seroxat) to Jordan.

• 2018 – First ever registration of PFS presentation of vaccines in GNE countries (2018).

• 2018 – Restate export prices of Engerix-B vials Adult & Paediatric in Oman which is used later on to protect the registered export prices in the neighbouring gulf markets.

• 2018 – Successful Transfer of operations of Multi-Markets Warehouse (MMW) in Jebel Ali Free Zone to a new 3rd Party Warehousing Services Provider without impact on supply.

• 2019 – UAE-Localisation of 22 SKUs (Transfer of Secondary Packaging & Quality Control Testing from foreign manufacturers to UAE-Local Manufacturers) on time.

• 2022 – UAE-Localisation of additional 12 SKUs (Transfer of Secondary Packaging & Quality Control Testing from foreign manufacturers to UAE-Local Manufacturers) on time.

June 2005 to August 2011 (6 Years)

Abu Dhabi International Medical Services Co., a Local Distributor in UAE Head of Pharmaceutical Division & Scientific Office for UAE’s Territory

– Establishment of a pharmaceutical division from scratch, including all divisions

(Regulatory Affairs, Marketing, Commercial, Supply Chain).

– Acquiring distribution rights of high potential products.

– Product screening, market analysis.

– Reviewing of distribution agreement.

– Forming and building up a second-generation team.

– Direct and lead a team of 10 pharmacists.

– Monitoring all operations to assure right track progress.

– Enable principal pharmaceutical companies to achieve their objectives;

– Introduction of the products into the healthcare providers (Public and private sector); Achievements:

• Establishment of Pharmaceuticals department inside the organisation.

• Acquiring Local Distribution Agreements for potential products that are first or second choice in their medical therapy as following:

o Fito (Fitostimoline) used for wound-care management, and now it is acquired by Leo; It is competitor of Bactroban (Mupirocin-GSK), Fucidin (Fucidic acidLeo) and Mebo (Herbal-Julphar).

o Kelocote (Silicon blend) used for scare management. o Arthrum H (Hyaluronic Acid) used for Osteoporosis.

o Amphotec (Colloidal Amphotericin B) used for systemic anti-fungal, and it is competitor of AmBisome, Abelcet and Pentostam (Stibogluconate SodiumGSK).

o Euvax B (rHBV-LG Vaccines Branch), and it is competitor of Engerix B

(rHBVGSK).

GAMAL ABU-AMER - CV 4

• Obtaining preliminary approval from multinational company to go into joint venture for establishing a local pharmaceutical manufacturing site in Abu Dhabi, UAE for technologies transfer of biological & vaccines; e.g. LGLS.

August 1992 to May 2005 (13 Years)

Modern Pharmaceutical Co (MPC), a Local Distributor in UAE Head of Regulatory Affairs & Compliance (1992 to 2005) Deputy Manager Governmental Affairs & Sales for Abu Dhabi branch (1992 to 2000) Manager of Warehouse & Supply Chain Abu Dhabi branch (1992 to 1997)

– Establishment of the regulatory affairs division from scratch

– Acquiring approval of the principal’s companies to undertake the regulatory affairs responsibilities on their behalves.

– Full responsibility of all regulatory affairs activities (First registration, variations, renewal, prices negotiations) on behalf of all principal companies, which included the following: Alcon (Novartis), Altana (Takeda), AstraZeneca, Baxter Oncology, Berna-Biotech

(Crucell), Bristol Mayer Squibb, Galderma, Grunenthal (Stada), Janssen Cilag, Lundbeck, Merck KGaA (Merck-Serono), Sandoz (Novartis), NV. Organon (MSD), Otsuka, Pharmacia-Upjohn (Pfizer), Sankyo, Rhone-Poulenc Rorer (Sanofi), Servier, Stada, Syntex

(Roche), UCB (GlaxoSmithKline), Viatris/Asta Medica (Meda), Wyeth (Pfizer) and ZLB

(CSL);

– Leading and building up second generation of regulatory affairs team;

– Efficient representing the multinational companies and enable them to achieve their objectives;

– Protection of the current business by licenses maintenance through product lifecycle;

– Efficiently deputy company manager for Abu Dhabi branch of Sales & Governmental Affairs

– Partial responsibilities for the warehouse and supply chain of Abu Dhabi branch. Achievements:

• Establishment of Regulatory department inside the organisation.

• Obtaining Regulatory Affairs Agreements with the above mentioned principals’ multination companies. Please refer to the attached list of NDAs.

• Adapting local regulations of UAE with the international regulatory legislations.

September 1984 to August 1992 (8 Years)

UAE GHQ Armed Forces, Directorate of Medical Services (Healthcare Provider), UAE Healthcare Products Purchasing Management:

– Responsible for procurement of healthcare products (medicines, medical equipment, sundries, non-medical hospitals items; and maintenance contract) from the local market.

July 1982 to August 1984 (2 Years)

Private Pharmacy, Cairo, Egypt

Pharmacy Manager

GAMAL ABU-AMER - CV 5

Jan 1980 to Jun 1982 (2.5 Years)

Obligatory Military Services

Egypt GHQ Armed Forces, Directorate of Medical Services, Cairo, Egypt Supply chains Manager Additional Information:

Additional Information:

Education: Bachelor of Pharmaceuticals Sciences

College of Pharmacy, University of Alexandria, Egypt Graduation Date: Jun-1979

Nationality: Egyptian

Marital Status: Married and has children

Date of Birth: 23-09-1956

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