# Pharmaceutical Regulatory Affairs in the Middle East: 2-Day Online Training Course (Apr 12-13, 2027) - eCTD Adoption and Regulatory Harmonization Drive Faster Market Access
- Published: 2026-11-13
- Author: [Healthcare News](https://healthcarenews.io/author/healthcarenews-io.md)
- Topics: [News](https://healthcarenews.io/news.md)
- Source: https://healthcarenews.io/news/pharmaceutical-regulatory-affairs-in-the-middle-east-2-day-online-training-course-apr-12-1/
- Publication: Healthcare News
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Dublin, Nov. 13, 2026 [(GLOBE NEWSWIRE)](https://www.globenewswire.com) -- "Pharmaceutical Regulatory Affairs in the Middle East (Apr 12th - Apr 13th, 2027)" has been added to **ResearchAndMarkets.com's** offering.
This Middle East pharmaceutical regulatory affairs course equips participants with practical knowledge of current regulatory requirements, submission processes and key developments across individual countries in the region.
Designed for professionals operating in a complex and rapidly evolving pharmaceutical market, the course examines the regulatory expectations that can influence product development, dossier preparation, submission planning and market access. Participants will gain insight into how national requirements vary across the Middle East and how these differences may affect regulatory strategies, timelines and operational decisions.
The programme also explores regional initiatives aligned with global pharmaceutical regulatory trends. Key areas include Common Technical Documents (CTD), electronic Common Technical Documents (eCTD) submissions and ongoing regional harmonisation efforts. These topics will help participants assess how internationally recognised submission frameworks are being implemented across Middle Eastern markets and identify considerations that may arise when preparing documentation for multiple jurisdictions.
A strong emphasis is placed on real-world application. Course content connects regulatory developments with the practical challenges faced by organisations seeking to register, maintain and manage pharmaceutical products in the region. Participants will be encouraged to consider how changing requirements can affect submission quality, internal processes, resource planning and communication with regulatory authorities.
**Key areas covered include:**
- Current pharmaceutical regulatory requirements in selected Middle Eastern countries
- Recent national and regional regulatory developments
- Regulatory submission planning for individual markets
- CTD and eCTD submission requirements and implementation
- Regional harmonisation initiatives and their potential impact
- Alignment between Middle East regulatory practices and global trends
- Practical considerations for preparing and managing compliant dossiers
- Approaches to navigating regulatory change across multiple jurisdictions
By developing a clearer understanding of country level expectations and regional developments, participants will be better prepared to support efficient regulatory planning and informed decision making. The course offers relevant insight for professionals involved in regulatory affairs, pharmaceutical development, quality, compliance, medical affairs, product registration, market access and related functions.
It may also benefit team members who collaborate with regulatory departments or contribute to submission documentation, lifecycle activities and regional commercial planning. The content is particularly relevant to organisations seeking to enter Middle Eastern pharmaceutical markets, expand an existing regional presence or strengthen their understanding of evolving regulatory frameworks.
Upon completion, participants will have enhanced their ability to identify important regulatory differences, evaluate submission expectations and understand the direction of regional harmonisation. They will also be better positioned to apply this knowledge when supporting pharmaceutical registration activities and adapting regulatory strategies to changing market requirements.
**CPD Hours: 12**
**Who Should Attend?**
This course will be of particular interest to:
- Personnel involved in pharmaceutical regulatory affairs in the Middle East
- Anyone new to the region e.g. Regulatory Affairs, Pharmacovigilance, Market Access and Business Development leads
- All those interested in an update on recent developments
**Speakers**
**Ilona Putz**
Ilona Putz is the founder and General Manager of PULONA Emerging Markets based in the UAE since 2008. Her company is dedicated to creating and developing tailor-made business concepts including regulatory consultancy for international manufacturers in the healthcare sector across the Middle East. Ilona has worked in the Pharmaceutical Industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard, HEXAL and Sandoz where she was the Regional Head, Middle East, for Sandoz International, Germany, responsible for all commercial and business development activities. She also consults for RegAff, Emergo and Dr. Regenold GmbH for the Middle East.Ilona spoke during the DIA Europe Meeting on "Clinical Trials in the Middle East" and at the Global Pharmaceutical Regulatory Affairs Summit 2021 and 2022.Moreover, Ilona published articles in the Journal of Medical Device Regulations on the regulatory overview for Medical Devices in Egypt, Kuwait and the UAE.
**Heba Hashem**
Heba has been working with Regulatory Affairs in the Middle East for more than 25 years. She has a Pharmaceutical and Business background being a graduate of the Faculty of Pharmacy (Cairo University), RAC certified in addition to an MBA at Maastricht School of Business. For the past 20 years Heba held the position of Middle East & Africa Regulatory and Quality Head at different Pharmaceutical and Medical Device companies; Gambro, Bayer and Novo Nordisk.
Heba is now the Middle East and Africa Associate Director at PPD where she is providing regulatory consulting services and training to Health Care companies.
For more information about this training visit https://www.researchandmarkets.com/r/hnylag
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