Our talk at 1:30 pm
“The Journey of a Medicinal Drug Product”: Ute Hegener and Dr. Emmanuel Bey follow a medicinal product from development and manufacturing through clinical trials and marketing authorisation to launch.
Trade fairs · Biotechnica
Pharma Solutions Day 2026
On 13 October 2026, Biotechnica hosts the Pharma Solutions Day in Algiers, on the theme from design to compliance. Ute Hegener and Dr. Emmanuel Bey give A&O Pharma's talk “The Journey of a Medicinal Drug Product” at 1:30 pm.
13 October 2026
Date
Algiers
Location
Sofitel Algiers Hamma Garden
Venue
An invitation-only event hosted by Biotechnica DWC-LLC, from 8:30 am to 4 pm. A&O Pharma's talk starts at 1:30 pm.
At Pharma Solutions Day 2026
What to expect from us.
The iMAH model
How manufacturers enter the EU market with A&O as interim Marketing Authorisation Holder, clinical trial applications and regulatory affairs.
Meet us on site
Ute Hegener and Dr. Emmanuel Bey are in Algiers all day. To follow up afterwards, reach us via the contact form.
Our talk · 1:30 to 2:15 pm
The Journey of a Medicinal Drug Product: from development and manufacturing through clinical development to marketing authorisation and launch
How does a medicinal product travel from development to the market in the European Union? Ute Hegener and Dr. Emmanuel Bey walk through it stage by stage, from the perspective of a service provider that accompanies each one itself. At its centre is the iMAH model: A&O applies for the marketing authorisation and acts as the interim marketing authorisation holder in the EU until it is transferred to a partner of your choice.
For manufacturers without a base in the EU, this is the shortest route, because only a pharmaceutical company established in the EU or the European Economic Area may place medicines on the market (Section 9(2) AMG). Find out more under Regulatory Affairs.
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01
Development and manufacturing
Develop and validate analytical methods, manufacture in line with GMP.
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02
Clinical development
Clinical trial applications and release of investigational products by a Qualified Person.
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03
Marketing authorisation
Regulatory strategy, dossier and application through to approval.
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04
Launch in the EU
With the iMAH model: A&O holds the authorisation until it passes to your partner.
Programme
The day at a glance.
- 8:30 to 9:00 Welcome, coffee and networking Biotechnica
- 9:00 to 9:30 Opening and introduction of Biotechnica Biotechnica
- 9:30 to 11:00 From biopharma ambition to local manufacturing Airplan
- 11:30 to 12:30 Airborne surface disinfection, contamination control strategy and data integrity DEVEA
- 1:30 to 2:15 The Journey of a Medicinal Drug Product, with the iMAH model Ute Hegener and Dr. Emmanuel Bey A&O Pharma
- 2:15 to 3:15 eCTD in the MENA region: preparing and managing submissions EXTEDO
- 3:15 to 3:45 Serialisation: from software to automated packaging HICOF
- 3:45 to 4:00 Closing and exchange with the experts Biotechnica
Background
Why Algiers.
Algeria has been expanding its pharmaceutical manufacturing for years. According to the Algerian Ministry of Pharmaceutical Industry, around 230 manufacturers operate in the country, and domestic production covers about 82 per cent of demand by value. Many of these manufacturers are now looking beyond their home market, to Africa and to Europe.
That is where we come in. Placing a medicine on the EU market requires a marketing authorisation, a marketing authorisation holder in the European Economic Area and a Qualified Person who certifies every batch. With its own manufacturing and import authorisation, regulatory affairs and the iMAH model, A&O Pharma offers this route from a single source.
The Pharma Solutions Day brings together the right topics: local manufacturing, GMP and data integrity, eCTD submissions and serialisation. The host is Biotechnica, a provider of integrated pharmaceutical solutions.
Frequently asked questions
Good to know.
When and where does A&O Pharma speak at the Pharma Solutions Day 2026?
On 13 October 2026 from 1:30 to 2:15 pm at the Sofitel Algiers Hamma Garden in Algiers. The speakers are Ute Hegener and Dr. Emmanuel Bey.
How does a manufacturer outside the EU place a medicine on the EU market?
It needs a marketing authorisation, a pharmaceutical company established in the EU or the European Economic Area that places the product on the market (Section 9(2) AMG), and an importer holding an import authorisation (Section 72 AMG) whose Qualified Person certifies every batch.
What is the iMAH model?
iMAH stands for interim Marketing Authorisation Holder. A&O applies for the marketing authorisation and acts as the marketing authorisation holder in the EU for a transitional period, until the authorisation is transferred to a commercial partner of your choice.
Does every imported batch have to be tested again in the EU?
As a rule, yes: for imports from outside the EU and the EEA, testing must take place in Germany (Section 17(1) AMWHV). This can only be waived if the conditions of Section 72a(1) sentence 1 no. 1 AMG are met, for example under mutual recognition agreements (Section 17(3) AMWHV). A&O tests these batches in its own GMP-certified laboratory in Itzehoe.
Can I arrange a meeting after the talk?
Yes. Talk to Ute Hegener or Dr. Emmanuel Bey on site, or write to us via the contact form. We will get back to you within 1 to 2 days.
Appointment in advance
Better arranged in advance.
At a trade fair there is little time for a conversation that goes into depth. Write us two lines beforehand and the appointment is fixed before you travel.
Propose a dateWhat we talk about there
Medicinal Product Release
Batch certification under Annex 16, by our Qualified Person (§ 14 AMG)
Regulatory Affairs
Marketing authorisation, iMAH and Life Cycle Management, from strategy to variation
Document Preparation
Site Master File, SOPs, PQR and CMC dossiers, prepared in your corporate identity
Secondary Packaging and Labelling of Investigational Medicinal Products
So your investigational medicinal products are labelled to comply with regulations and can be safely administered at the study site
