Publications & Engagements

MT&PP Presenting photoI am active in promoting best practice through authorship and presentation at established conferences.

YOUR organisation can benefit from customised material being delivered via private sessions with your leadership, staff or project teams.

Upcoming Engagements:

  • Speaker: “The EU regulatory framework for injectable delivery systems”, Injectable Drug Delivery, Management Forum, London, Mar 28/29, 2019
  • Speaker: “Integrated combined drug-device products in Europe”3rd Annual Drug/Device Combination Products Summit, VonLanthen, Amsterdam, Apr 10/11, 2019
  • Trainer: “Device Development – Challenges and Considerations” with Case Studies for Inhaler development, AutoInjector development, and Integrating Design Controls, Risk Management and Human Factors Engineering, Design Control for Drug-Device Combination Products, ECA, Copenhagen, May 16/17, 2019
  • Trainer: “Drug-device Combination Products: Major Changes Ahead!”, TOPRA CRED Course, TBD, May 2019

Recent Publications:

  • Co-author: ‘Article 117 of the Medical Device Regulation – An urgent need for further guidance.’, TOPRA Regulatory Rapporteur, Part 1 (May 2018) Part 2 (June 2018 issue).
  • Contributor: ‘The new EU Medical Device Regulations – Implications for inhalation devices.’, ONDrugDelivery, Issue 85 (April 2018)
  • Introduction Co-Author: ‘Global Medical Device Regulatory Strategy.’, Gropp & Takes, RAPS. ISBN: 9780996949132
  • Chapter Co-Author: ‘Combination Products- Implementation of cGMP Requirements.’, Hornback, PDA. ISBN: 193372272X

Recent Conference & Speaking Engagements:

  • Speaker: “Considerations for different types of drug/device combination products”, Drug/Device Combination Products Summit, Qepler, Berlin, Dec 4/5, 2018
  • Trainer: “Drug-Device Combinations“, TOPRA Module 8 Masterclass, Chesham UK, Nov 30, 2018
  • Speaker: “Trends and challenges of Drug-Device Combination Products“, Inauguration of the new Fill/Finish Plant, Corden Pharma, Caponago, Nov 5, 2018
  • Speaker: “Combination Products – Exploring regulatory similarities and differences between US and EU“, Combination Products Forum, IQPC, Amsterdam, Oct 30/31, 2018
  • Chair: TOPRA Annual Medical Devices Symposium, Session 5 “Combined Human Medicines and Medical Devices: Medicinal products with integral medical devices“, Stockholm, October, 2018
  • Speaker:  “Latest technical, quality, and regulatory considerations for injection devices“, 4th Annual Pre-Filled Syringes Summit, VonLanthen, Amsterdam, Sept 20/21, 2018
  • Speaker: “The impact of the MDR, Art.117“, Pre-Filled Syringes Summit 2018, Qepler, Berlin, May 31/Jun 1, 2018
  • Trainer: “Device Development – Challenges and Considerations” with Case Studies for Inhaler development, AutoInjector development, and Integrating Design Controls, Risk Management and Human Factors Engineering, Design Control for Drug-Device Combination Products, ECA, Prague, May 17/18, 2018
  • Speaker: “Drug-device products and the impact of MDR“, 12th CMC Strategy Forum EU, CASSS, Berlin, May 15/16, 2018
  • Speaker: “Clinical studies and your drug delivery device“, 2nd Annual Drug/Device Combination Products Summit, VonLanthen, Berlin, April 2018
  • Attendee: RAPS: Building the Scientific Bridge for Comparability of Combination Products, Rockwell, MD, Nov 30, 2017
  • Attendee: PDA Universe of Prefilled Syringes and Injection Systems, Vienna, Nov 7/8, 2017
  • Attendee: MedTech and Pharma Platform, Basel Switzerland, Oct 26/27, 2017
  • Speaker: “An Overview of Regulations, Technology and Advances”
    • Wearable Drug Delivery, Management Forum, London UK, Oct 16/17, 2017
  • Attendee: TOPRA Annual Medical Device Symposium, London UK, Oct 3/4, 2017
  • Speaker: “Regulatory Landscape – PFS … and other injection systems.”
    • VonLanthen 3rd Annual Pre-filled Syringes Summit, Barcelona, Sept 28-29, 2017
  • Trainer: “Device Development – Challenges and Considerations” with Case Studies for Inhaler development, AutoInjector development, and Integrating Design Controls, Risk Management and Human Factors Engineering.
    • Design Control for Drug-Device Combination Products, ECA, Hamburg, May 2017
  • Speaker: “Drug-Device combinations – Is the message getting across?”
    • Injectable Drug Delivery, Management Forum, London, Mar 2017
  • Speaker: “Differences & Similarities between Europe and US Registration Strategies.”
    • PDA Universe of Prefilled Syringes & Injection Devices, Huntington Beach, CA, US, Oct 2016
  • Speaker: “Technology Transfer.”
    • PDA Drug Delivery Combination Products Workshop, Huntington Beach, CA, US, Oct 2016
  • Speaker: “Innovative and challenging drug delivery devices – perspective from a pharma device engineer.”
    • TOPRA Annual Medical Device Symposium, Amsterdam, Sept 2016
  • Speaker: “Design Control for Pre-filled Syringes.”
    • VonLanthen 2nd Annual Pre-filled Syringes Summit, Berlin, Sept 2016
  • Trainer: “Device Development – Challenges and Considerations.” with Case Studies for Inhaler and AutoInjector development
    • Design Control for Drug-Device Combination Products, ECA, Barcelona, May 2016
  • Speaker: “Drug Delivery Combination Products.” – 2 day training event
    • 2016 PDA Europe Conference – Parenteral Packaging, Venice, Apr 2016
  • Speaker: “Leveraging a device platform – some of the considerations.”
    • Injectable Drug Delivery, Management Forum, London, Mar 2016
  • Panellist: “The importance of Needle Stick Protection – Assessing the safety.”
    • 8th Annual Conference on Pre-Filled Syringes, SMi, London, Jan 2016
  • Speaker: “The challenges of the pre-filled syringe combination product.
    • 10th Drug Device Combination Products, Informa, Berlin, Nov 2015
  • And many more….

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