PDA Annual Meeting 2019 – Part 1

Challenges of the Future

Falk Klar, European Director of the Parenteral Drug Association, talked about the future challenges in the branch:

• Automation and robotics
• Virtual reality and augmented reality
• Blockchain and artificial intelligence
• 3D printing and 3D bio-printing
• Personalized medicine, precision medicine
• Empowered patients 

Conference speakers covered most of the topics and gave great insight into the current thinking of regulators and industry. 

Did you already have time to study these topics in your daily business? If not, you missed an outstanding event! The speakers gave deep understanding into activities of colleagues, competitors and service providers. 

Decision Making under Uncertainty

This was the keynote title of Felix Rebitschek, PhD, from the Max Planck Institute for Human Development.

"People underweight outcomes that are merely probable in comparison with outcomes that are obtained with certainty."

He talked about the rationale and non-rationale decision making from the scientific view. 

This has an impact on nearly everybody in the daily business, e. g.: Risk need only calculation and optimization if you have all decision alternatives, consequences, and probabilities available. The problem is often communicating the risk and the information behind the numbers. Also, scientifically trained people are influenced by different biases.

Felix Rebitschek said: "It is a big problem that numbers are often not presented adequately to people." And he also talked about decision making in teams where he focused on the intuition of people.

Focus on better clarity of communication: Everybody should understand what the sender wants to say. 

Back to the example, he showed that decision trees with easily understandable interrelations are a key to better and clear communication. Because it is very important to communicate risk and uncertainties to people in a way that they understand it.

He referred to Stephen J Gould:

"Our species is uniformly probability-blind."

And this influences our daily decisions also in the scientific environment. 

EMA is continuously making progress

Brendan Cuddy from EMA updated the audience on EU regulatory activities.

First, he promised that Germany will be soon accepted through the EU-US MRA (Mutual Recognition Agreement). And that promise has now been kept. Germany was recognized on June 27. In the meantime, also the Slovak Republic has been found capable. And with that, the MRA became fully operationable on July 11.

Brexit is a big issue at the agency. EMA calls on all pharmaceutical companies to stay prepared for all options. There are EMA-EC published guidance about operational preparedness.

Another draft of Annex 1 (EU Guide to GMP) is expected to be ready in September 2019 during the next meeting of the GMDP Inspectors Working Group. The message is: We will not get a final version soon, but additional work with another draft of the guide.

Brendan Cuddy reported also from the N-nitrosamines contamination case from last year. Many of the risk assessment conducted by some manufacturers were incomplete and/or insufficient. He talked about the real root causes coming up after a long examination of the case.

EMA wants to shift like industry from a reactive to proactive risk management. So, EMA is focusing on training and knowledge management, building QRM competencies, effective and proportionate evaluation of risk to quality.

Quality Metrics are Key Numbers for Regulators and Industry

Patients expect safe and effective medicines with every dose they take. Tara Goon, US FDA, started with the patient view of her talk.

She focused on the FDA Quality Metrics Initiative.

Many products in other industries are made using Quality Metrics to monitor quality control and continually improve products and process quality. Drugs should make no difference! A business should and can benefit from Quality Metrics. KPIs (key performance indicators) make sense for a regulator, too. Important is also to incorporate cultural excellence.

The „Pharmaceutical Production System Model-House“ was also part of her talk. Excellence, effectiveness, and efficiency are covering all structural factors. These are supplier reliability, operational stability, lab-quality, and robustness. Also, CAPA effectiveness and cultural excellence are covered factors.

Which Quality Metrics are interesting for the FDA?

Tara Goon mentioned the following KPIs in her clear presentation:

• Lot Acceptance Rate (robustness of the commercial manufacturing process)
• Invalidated Out-of-Specification Rate (robustness of lab operations)
• Product Quality Complaint Rate (voice of the customer)

FDA is still in the learning mode and will make continuously progress.

MHRA does more than Brexit preparations

„This is not a presentation only on Brexit.“ With these words opened David Churchward from the MHRA his talk at the PDA EU Annual.

MHRA is preparing for every scenario. He stated that there will be a close collaboration with the EU colleagues after the Brexit - in every case.

David Churchward delivered some details on accepting current practices (marketing authorization, packaging in EU, ...) for the next years to have drugs available in the UK.

A new national IT portal was implemented to have it in place when exiting the EU. It is ready to use and manufacturers can get access to the web portal.

Further information about the Brexit can be found here.

Priorities of the MHRA are:

• Patient access
• UK life sciences
• Reduction of industry burden

UK is working in MRAs with „listed countries“ outside the EU, signed with USA, CH, NZ, OZ, ISR, in progress is JPN and CAN.

Responsible Person for UK import: This is a new function in UK law.

David Churchward also explained the process for imports from the EU/EEA.

He also talked about future topics like innovative supply chains, pharma & environment incl. plastic packaging tax and MHRA operational transformation.

PIC/S is the Pioneer of Harmonization

The vision of the PIC/S (Pharmaceutical Inspection Co-operation Scheme) is: To lead the international development, implementation & maintenance of harmonized GMP standards & quality systems of inspectorates in the field of medicinal products. Anne Hayes title was „PIC/S Vision, Reality, Aspiration“.

Anne Hayes reminded us of the importance of this organization, its foundation, and its values. The goals of PIC/S are:

• Mutual recognition of inspections
• Harmonisation of GMP requirements
• Uniform inspection systems
• Training of inspectors
• Exchange of information
• Mutual confidence

The PIC/S Inspectorates Academy is an important initiative to increase the harmonization of regulatory inspections. It was formed in 2014 and it provides a platform for the training material for authorities.

In 2014 they created a "Professional Inspectors’ Academy” (PIA) to deliver courses for Inspectors ranging from general training to highly specialised training. Training of inspectors and availability of the various training tools are fundamental for the harmonisation of GMP, which is intrinsic to PIC/S’ mission. PIA aspires to harmonise and standardise GMP training for PIC/S members through a recognised qualification system.

She gave also an insight into the ICMRA (International Coalition of Medicines Regulatory Authorities). It is a GMP reliance network working together to accept inspections.

A new PIC/S Guidance on GMP Inspection Reliance (PI48-1) came into force on 1 June 2018.

• Provides a framework to help Competent Authorities (CA) prioritise resources for GMP inspections for human and veterinary medicines
• Outlines a process for desk-top assessment of GMP compliance of overseas facilities to identify instances where an acceptable level of GMP compliance can be confirmed and assured from the activities of another CA or CAs without the need for an on-site inspection
• is non-binding (i.e. applicable voluntarily) and is a high-level guidance for PIC/S Participating Authorities (PA)

PIC/S is doing a great job and nobody wants to miss their engagement in global GMP harmonization. Nevertheless, PIC/S is always faced with challenges in the areas of politics, legislation, and practice.