Trade fairs · Algiers
Pharma Solutions Day 2026
On 13 October 2026, Biotechnica hosts the Pharma Solutions Day in Algiers under 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.
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.
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 get from development to the market in the European Union? Ute Hegener and Dr. Emmanuel Bey walk through the journey stage by stage, from the perspective of a service provider that supports every stage itself. At its centre is the iMAH model: A&O applies for the marketing authorisation and acts as interim marketing authorisation holder in the EU until the authorisation is transferred to a partner of your choice.
For manufacturers based outside the EU, this is the shortest route, because only a pharmaceutical company established in the EU or the European Economic Area may place medicinal products on the market (§ 9(2) AMG). Find out more under Regulatory Affairs.
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01
Development and manufacturing
Developing and validating analytical methods, manufacturing in line with GMP.
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02
Clinical development
Clinical trial applications and certification of investigational medicinal 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 marketing authorisation until it is transferred to your partner.
Programme
The day at a glance.
- 8:30 to 9:00 am Welcome, coffee and networking Biotechnica
- 9:00 to 9:30 am Welcome address and introduction to Biotechnica Biotechnica
- 9:30 to 11:00 am From biopharma ambition to local manufacturing Airplan
- 11:30 am to 12:30 pm Airborne surface disinfection, contamination control strategy and data integrity DEVEA
- 1:30 to 2:15 pm 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 pm eCTD in the MENA region: preparing and managing submissions EXTEDO
- 3:15 to 3:45 pm Serialisation: from software to automated packaging HICOF
- 3:45 to 4:00 pm Closing session and Q&A 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 medicinal product 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 (MIA), regulatory affairs and the iMAH model, A&O Pharma offers this entire route from one provider.
The Pharma Solutions Day brings together the right topics for this: 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 is A&O Pharma speaking 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 can a manufacturer from outside the EU place a medicinal product 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 (§ 9(2) AMG), and an importer holding an import authorisation (§ 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 retested in the EU?
As a rule, yes: for imports from outside the EU and the EEA, the batch must be tested in Germany (§ 17(1) AMWHV). Exceptions apply only where the conditions of § 72a(1) sentence 1 no. 1 AMG are met, for example where a mutual recognition agreement (MRA) covers the product (§ 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 contact us via the contact form. We will get back to you within 1 to 2 days.
