This one-day course will provide you with an in-depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region regarding generic submissions.
Attendees will receive a detailed explanation of the specific requirements for documents and studies required in generic submissions, with the most common inquiries raised by reviewers to consider. This in turn will assist in avoiding a long list of inquiries that may delay your registration process.
Similarities and differences between the requirements in MENA regions, USA and EU will be discussed.
This is an excellent opportunity to discuss the complexities involved with an expert in this geographic region.
Benefits of Attending
- Become more familiar with the regulatory environment and framework in the MENA region
- Understand how to compile effective CTD submissions
- Be aware of the specific requirements that should be considered when submitting registration dossiers in major countries in the MENA region
- Learn the most common deficiencies and inquiries raised by the reviewers
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Course Content
Overview of the Pharmaceuctical Market in the MENA Region
Format Used by Different MENA Countries (Traditional Registration Dossiers, CTC or eCTD)
Module 1 - Regional Requirements
- Pharmacovigilance requirements
- Product information requirements (Labeling, SPC & PIL)
Module 3 - Quality - CMC (Important Considerations for Specific Sections in Module 3)
- 3.2.S (S-part) and different options for submission
- Data requirements for 3.2.P (P-part)
- 3.2.R regional requirements
- Analytical procedures
- Analytical method validation
- Impurities
- Stability testing requirements
Life cycle management (Variations)
Summary of Module 3 (Product Overall Summary) and Different Formats of Submitting Module 2
Module 5 - Clinical
- Bioequivalence requirements
eCTD Required Technical Specifications
Regulatory Framework Examples (GCC & Egypt)
- New submissions, variations and renewals
Smilarities and Differences Between CTD Requirements in MENA Region, USA & EU
Course Provider
Mohammad Fat'hy Elnadi,
Independent Pharmaceutical ConsultantMohammad has a unique blend of both technical and regulatory experience and qualifications gained from his more than 18 years of experience in the pharmaceutical industry. After graduating in pharmaceutical science from the University of Cairo, he has held posts in the fields of R&D and production of pharmaceutical dosage forms, and as a contract manufacturing coordinator.
After completing a postgraduate certificate in management from the American University in Cairo (AUC), he has held senior management roles in business development in the pharmaceutical industry, including opening new markets in local and export markets, which allowed him to deal with different regulatory health authorities and business environments.
He successfully led his team in cooperation with colleagues from other departments within various companies in numerous market access projects in many African countries, ASEAN, GCC and other Middle East Countries.He has also been responsible for the establishment of supply chain departments in many pharmaceutical companies. Leading planning, local and foreign purchasing, and warehouse functions.
Mohammad is now a regulatory consultant for many pharmaceutical companies. He is an international speaker, providing courses and webinars worldwide in regulatory affairs and supply chain topics related to the pharmaceutical industry.
Who Should Attend
This course has been designed for professionals of the pharmaceutical industry who are currently, or planning to become involved in the development of regulatory submissions to MENA regions using CTD/eCTD. The programme is particularly suitable for project team members interested in gaining a practical understanding of regulations, tools, and required submission processes. This includes professionals working in but not limited to:
- Regulatory Affairs
- Export drug regulatory affairs
- R&D
- Documentation Teams
- Quality Control
- Quality Assurance
- Anyone interested in understanding the regulatory environment and requirements in MENA region
