The Regulatory Challenges With Combination Products

The Regulatory Challenges With Combination Products
Developing a combination product that integrates pharmaceuticals and medical devices presents unique challenges. During the evening, we will explore regulatory requirements and solutions that facilitate the transition of such products into clinical use, ensuring they reach the patients who need them. We will also receive the latest updates regarding TOPRA. This event offers an opportunity to connect with colleagues in a relaxed and pleasant environment. The meeting is open to anyone working with or interested in regulatory affairs.

Book now. In person event only.

Venue: GoCo, Entreprenörsstråket 10, Mölndal Gothenburg

6 - 6.30pm Light refreshments

6.30 - 6.35pm - Introduction: Margareth Jorvid, Alzinova

6.35 - 7.05pm - Development and CE Marking of XVIVO Heart Assist Transport (TM)

Speaker: Petra Rosen, XVIVO

- Regulatory Classification
- The CE Marking Process
- Experiences

7.05 - 7.35pm Dosage Manager Dispenses Solid Oral Medications Such as Granules and Pellets at the Touch of a Button

Speaker:  Fredrik Mannerstrale, OnDosis

- Combines easy to use hardware with intuitive software
- Experiences 

Short break

7.50 - 8.20pm Trixeo Aerosphere: A Triple Combination (formoterol, glycopyrronium and budesonid) in a single inhaler, used for the maintenance treatment of COPD

Speakers: Helena Hultman & Emilia Heimann, AstraZeneca 

- Regulatory pathway to market
- Experiences

8.20-8.30pm TOPRA News, Margareth Jorvid, TOPRA volunteer

8.30 -9pm Networking and close 

MPA employees can email membership@topra.org to register for free

Presentations in Swedish


Pricing

 Standard webinar registration fees
 Webinar Registration Type Price (GBP)
 Standard Price 
 TOPRA Member		 FREE
 Standard Price
 Non-member		 £60.00



 

 

 

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Sign up for 2027 and enjoy the remainder of 2026 for free.  Contact membership@topra.org for details. 

 
When
17/11/2026
Where
Medicon Village GOTHENBURG SWEDEN
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