Conference

report

AESGP REGULATORY CONFERENCE

20 March 2019 | Amsterdam, The Netherlands

The AESGP Regulatory Conference in Amsterdam follows a long-standing tradition of facilitating exchange between
the self-care industry and regulators. The conference welcomed more than 100 medicinal products and medical de-
vices regulators, consumer health industry professionals and other stakeholders, who discussed the opportunities
and challenges of the evolving regulatory environment marked by digitalization, the MDR implementation and cen-
tralised switch experience.

Digital transformation of regulatory science and healthcare

The first session addressed the digital transfor-

mation of healthcare and selfcare, outlining the
opportunities digital technologies can bring to
regulatory science, product evaluation and risk
management. From development of common
information technology (IT) services to the im-
plementation of European pharmaceutical poli-
cy and legislation to machine learning, there are
now a multitude of options to choose from to
drive operational improvements in addition to
more strategic innovation. European regulators
are increasingly turning their attention to the
greater use of real world evidence (RWE) and
real world data (RWD) that are often harnessed
by use of digital technology to enrich the
source of evidence alongside those collected
from clinical trials. New emerging technologies
may not only improve cost-effectiveness and
efficiency of pharmacovigilance, but also enable
citizens to look after their health, stimulate pre-
vention and enable feedback and interaction
between users and healthcare providers.
From left to right: Jurate Svarcaite, AESGP Director-General; Guido Rasi,
Chaired by Jurate Svarcaite, AESGP Director Executive Director of the European Medicines Agency (EMA); Andrzej Rys,
General, the session brought together panelists Director of Health Systems, Medical Products and Innovation, Directorate
from the European Commission, the European General Health and Food Safety of the European Commission; Karl
medicines regulatory network as well as Indus- Broich, Chair of the EU Telematics Management Board and Director Ge-
try. neral of the Federal Institute for Drugs and Medical Devices (BfArM), Ger-
many; César Hernández, Head of the Department of Medicines for Hu-
man Use at the Spanish Agency for Medicines and Medical Devices
Guido Rasi, Executive Director of the European (AEMPS); Giovanna Ferrari, Regional Labelling Lead, International Label-
Medicines Agency (EMA), presented the new ling Group (Pfizer); and, Sabine Strauss, Chair of the EMA Pharmacovigi-
EMA Regulatory Science to 2025 Strategy, fo- lance Risk Assessment Committee (PRAC)
cusing on 3 out of five goals set out in the strategy,
namely (1) catalyzing the integration of science and
technology in drug development, (2) driving collabora-
tive evidence generation and improving the scientific
quality of evaluations and (3) advancing patient-
centered access to medicines in partnership with
healthcare systems.
Andrzej Rys, Director of Health Systems, Medical Prod-
ucts and Innovation, Directorate General Health and
Food Safety of the European Commission, presented
the European Commission’s e-Health strategy which
adopts a person-centric approach to healthcare where
citizens have secure access to their health data, can
benefit from personalized medicine and are empowered
with digital tools to provide feedback and benefit from
person-centered care.
Karl Broich, Chair of the EU Telematics Management
Board and Director General of the Federal Institute for
Drugs and Medical Devices (BfArM), Germany, provided
insights into the EU telematics strategy and highlighted
the importance of efficient governance of EU telematics.
Common information-technology services once fully
implemented will optimize support to the EU regulatory
network. He shared successes and key lessons learned
from the Telematics Strategy 2015-2018 and recognized
that a reprioritization of activities was needed due to
the relocation of the Agency and UK exit. The main chal-
lenge was to build a structure that caters for different
types of products and different disciplines. He also pre-
sented the ongoing work of the Joint Heads of Medi-
cines Agencies (HMA) and EMA taskforce on Big Data.
The Taskforce will generate a list of recommendations
including characterization of relevant sources of big
data and will define the standards for data format to
ensure interoperability.
Implementation of the Medical Devices Regulation
The second session provided an update on the imple-
mentation of the Medical Devices Regulation (MDR)
which will be applied from 26th May 2020.
The session was chaired by Maud Perrudin, AESGP
Deputy Director General, who gave insight into AESGP
work with regard to the implementation of the MDR
with a particular focus on self-care medical devices that
are composed of substances or combination of sub-
stances (such as saline solution nasal sprays, creams to
treat or prevent minor skin irritations or anti-flatulence
products). These are classified as devices in light of their
mode of action which is not pharmacological, immuno-
logical or metabolic but relies on chemico-physical pro-
cesses such as local pH changes, sequestering actions of
molecules, and physical barrier formation. The scope
and complexity of the MDR are proving challenging for
all stakeholders involved with the implementation of the
new regulation, especially as regards their capacity and
expertise.
César Hernández, Head of the Department of Medi-
cines for Human Use at the Spanish Agency for Medi-
cines and Medical Devices (AEMPS), presented the on-
going work on eProduct Information; further noting the
advantages of a digital version, such as the ability to
provide up-to-date product information instantly after
regulatory decision, the possibility to provide video con-
tent... Various initiatives by national regulators, EMA, EC
were converted into a single project led by the EMA, the
Heads of Medicines Agencies (HMA) and the Commis-
sion. The goal of the initiative was to define the steps
for the development of a flexible implementation of the
ePI in the EU and initiate discussions on an EU-wide
process and common technical standard.
Sabine Strauss, Chair of the EMA Pharmacovigilance
Risk Assessment Committee (PRAC), shared challenges
that regulators faced when evaluating the benefit-risk
balance of medicines and gave examples of non-
prescription medicines that were recently discussed by
PRAC. The regulatory landscape was changing from
population to individual focus, from mono to complex
therapies, etc. and RWD and RWE are becoming a criti-
cal part of pharmacovigilance, offering the possibility to
gain complementary evidence for signal validation as
well as risk minimisation. She concluded that, if real
world data were collected, structured and used in an
appropriate manner, this could have a revolutionary
impact on pharmacovigilance.
Giovanna Ferrari, Regional Labelling Lead, International
Labelling Group (Pfizer), presented a project led by the
pharmaceutical industry on a solution for integrated
patient-centric digital health information. It aimed to
develop a technology platform and digital solutions to
provide content tailored to patient needs, the possibility
to have multiple versions and formats of the same au-
thority-approved ePI and to allow engagement with the
individual that would lead to better adherence and im-
proved health outcomes.
Helena Dzojic, Head of Department of Medical Devices,
the Swedish Medical Products Agency, and newly elect-
ed Chair of Competent Authorities for Medical Devices
(CAMD) Executive Group, shared her views on the role
and priorities of CAMD in this critical phase of the MDR
including the identified opportunities for collaboration
with the HMA Management Group.
Zaide Frias, Head of Human Medicines Evaluation Divi-
sion, EMA, provided the EMA perspective on the imple-
mentation process regulation considering the new roles
and responsibilities mandated to the EMA as well as
national medicines authorities by the MDR. Referring to
the discussion from the first session, it was noted that
digitalization brings about new kinds of medical devices
and different digital tools which offer huge potential,
yet can add additional burden to the existing regulatory
activities. An update was provided on the ongoing EMA
activities regarding the borderline and classification
work, the MDR consultation procedure of medicines
authorities applicable to substances based medical de-
vices falling under Rule 21, and the guidance docu-
ments developed in relation to Article 117 MDR
(medicinal product with an integral medical device.).
Françoise Schlemmer, Director of the European Associ-
ation of Medical Devices Notified Bodies (TEAM-NB),
presented the impact on the notified bodies. She shared
the results of the TEAM-NB recent survey on the noti-
fied bodies’ designation process under the MDR and
IVDR, which indicate the increase in the number and
scope of the applications for designation and the ongo-
ing capacity building.
Oliver Bisazza, Director, Regulations & Industrial Policy,
MedTech Europe, reminded the audience of the various
showstoppers for the MDR system readiness and called
for lead-time between the readiness of the system and
application in practice. A reasonable transition period is
needed in order to make sure that products are compli-
ant and can be reviewed by notified bodies on time to
remain on the market. Most urgently, he recalled that
sufficient Notified Body availability capacity must exist
many months before the dates of application. Conclud-
ing the session, Maud Perrudin insisted that appropriate
expertise to assess substance based devices was critical-
ly needed. Regulators and notified bodies yet too often
start by considering look-like-medicines products as
medicines without carrying a case-by-case assessment.
Furthermore, once it is considered a medical device,
substance-based products need to be looked at individ-
ually to determine the applicable risk class. AESGP posi-
tion papers on Rule 14 and Rule 21 have been devel-
oped to assist in such exercise.

From left to right: Maud Perrudin, AESGP Deputy-Director General; Helena Dzojic, Head of Department of Medical Devices, the
Swedish Medical Products Agency, and newly elected Chair of Competent Authorities for Medical Devices (CAMD) Executive Group;
Zaide Frias, Head of Human Medicines Evaluation Division, EMA; Françoise Schlemmer, Director of the European Association of Medi-
cal Devices Notified Bodies (TEAM-NB); and, Oliver Bisazza, Director, Regulations & Industrial Policy, MedTech Europe.

10 years since the first centralised switch. What have we learnt?

The third session, chaired by Christelle Anquez-
Traxler, Regulatory and Scientific Affairs Manager at
AESGP, took stock of the lessons learnt in the ten years
since the first centralized switch and discussed the way
forward. There have been four successful changes of
legal status from prescription to non-prescription (so-
called ‘switch’) through the centralized marketing au-
thorization procedure since the procedure became ac-
cessible for a switch: orlistat, pantoprazole, esomepra-
zole and ulipristal.
Professor Claudio Jommi, Professor of Practice of Gov-
ernment, Health and Not for Profit at SDA Bocconi
School of Management, set the scene of the session by
presenting the results of a recent Italian economic study
on the potential economic and social benefits of reclas-
sification. It showed a potential savings of 1.1 to 2.4 bil-
lion Euros collectively to employed patients and to na-
tional health expenditure.
Ilaria Passarani, Secretary General of the Pharmaceuti-
cal Group of the European Union (PGEU), further
stressed the value of switching, not just in addressing
the burden faced by the national health systems, but
also for patient empowerment and ease of access. In
addition, self-care contributes to the role of pharmacists
evolving and going beyond dispensing the product to
providing services.
Gabriella Grippaudo, Senior Director Regulatory &
Medical Affairs EMEA, Pfizer Consumer Healthcare, pre-
sented the success factors in the switching of
esomeprazole but also cautioned on the need for flexi-
bility and agility in the regulatory routes to access to
From left to right: Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager (AESGP); Professor Claudio Jommi, Professor
of Practice of Government, Health and Not for Profit at SDA Bocconi School of Management; Ilaria Passarani, Secretary General of
the Pharmaceutical Group of the European Union (PGEU); Gabriella Grippaudo, Senior Director Regulatory & Medical Affairs EMEA,
Pfizer Consumer Healthcare; Helene Guillard, Global Rx-to-OTC Switch Director, HRA Pharma; and, Zaide Frias, Head of Human Me-
dicines Evaluation Division, EMA

market, citing the case of "Viagra Control", which was
switched nationally in the UK.
For Helene Guillard, Global Rx-to-OTC Switch Director,
HRA Pharma, the centralised procedure was a game
changer for ellaOne which gave access to an additional
40 million more women. The key to the success of the
switch was the “switch by design” approach, which en-
tailed an early start of the project, the use of the Brass
benefit-risk methodology and addressing the concerns
proactively through collecting clinical data to address
gaps. However the pure national launch following the
positive EC decision is in itself another challenge.
According to Zaide Frias, Head of Human Medicines
Evaluation Division, EMA, the Agency never expected a
high amount of switch applications but rather innova-
tive, first in line switches. The introduction of Joint EMA/
CMDh Multi-Stakeholder Scientific Advice procedure,
for which AESGP has been continuously advocating, and
the establishment of which is currently on hold due to
Brexit, would be a welcome platform for early discussion
with the presence of different stakeholders. Digital
transformation, especially the changing data landscape,
could also contribute to overcoming a number of hur-
dles to switching and unleash the potential of the cen-
tralized procedure in particular for new indications and
innovation.

Conclusions

Hugo Hurts, Executive Director, Dutch Medicines Evaluation Board (MEB), on behalf of regulatory authorities, and
Birgit Schuhbauer, AESGP President and Global Vice-President strategic marketing OTC, Johnson & Johnson, on
behalf of the industry, summed up the discussions of the conference. Hugo Hurts commended AESGP on the format
of the conference, while Birgit Schuhbauer reflected on the results of the conference and how they fit into the overall
AESGP strategy.

Digitalization of regulatory science and healthcare provides a unique opportunity to drive operational im-
provements as well as more strategic innovation in regulation and, most importantly, to implement person-
centered care. European regulatory network for medicines and medical devices is intended for the benefit of
all citizens; the consumer health Industry is prepared to play its role in the ongoing developments and espe-
cially when implementing the medical devices regulation and improving access to non-prescription medicines
across Europe.

Self care: The first choice in healthcare

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