Newsletter

Patient involvement in the development, regulation and safe use of medicines
30 September 2022 | Giuliana Miglierini

The newly published CIOMS report discusses the best practices that may be implemented along the entire lifecycle of a medicine, medical device, diagnostic or combination product in order to capture and consider the patient’s point of view from the very early phase of development down to regulatory processing, and post-marketing monitoring. Case studies are also provided to better explain the possible approach to different activities, including for example formulation development and regulatory public hearings
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Real-world evidence for regulatory decision-making
23 September 2022 | Giuliana Miglierini

A ICRMA’s joint statement and the new Big Data Workplan 2022-2025 jointly issued by EMA and HMA pave the way to the implementation of the use of big data analysis for regulatory decisionmaking. Some still open issues shall be address by discussion among the stakeholders, according to the detail timeline proposed in the workplan
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ACT EU’s Workplan 2022-2026
16 September 2022 | Giuliana Miglierini

The Workplan 2022-2026 published by the European Commission, EMA and the HTA highlights the actions identified to pursued the ten priorities identified by ACT EU and provide a brief description of key deliverables and their associated timeline
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EFPIA’s Annual Report on the Pharmaceutical industry 2022
9 September 2022 | Giuliana Miglierini

The Annual Report of the Federation of the European Pharmaceutical Industry Associations indicates the sector is still in good health, but suffers from the competition of more attractive economies. The length of the R&D process to reach the market together with regulatory barriers and the fragmentation typical of the European countries are still issues to be solved
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Trends in Drug delivery and Formulation
5 August 2022 | Giuliana Miglierini

The 2021 Global Drug Delivery & Formulation Report highlights the recent trends in approvals of new drug formulations and drug delivery technologies. Injectable and oral products maintain the leading positions, but new approaches are emerging, for the example in the case of nasal delivery to treat ocular conditions
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The new European Innovation Agenda
29 July 2022 | Giuliana Miglierini

The five areas of intervention of the new European Innovation Agenda announced by the EU Commission include investments to support startups and scaleups, development of regulatory sandboxes, initiatives to attract talents and to standardise the terminology used to draft policies and the creation of a network of regional innovation valleys
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ICMRA, two pilot programmes to optimise regulatory assessment and inspections Summary
22 July 2022 | Giuliana Miglierini

Collaborative assessments of CMC and post-approval change submissions and hybrid inspections are the focus of the two one-year pilot projects launched by ICRMA in order to better harmonise procedures and expectations at the global level. A greater flexibility of regulatory procedures across different regions based on sharing of best practices and standards, collaborative inspections and alignment of procedures are among the main expected outcomes
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EMA’s Industry stakeholders group (ISG)
15 July 2022 | Giuliana Miglierini

The ISG will act a specific reference point to support the dialogue of EMA with the industrial counterparts, under the new extended mandate. The three key areas of interest during the pilot phase are the Emergency Task Force, the shortages of critical medicines and medical devices and the experts groups on medical devices.
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Current inspection trends and new approaches to the monitoring of post-inspection activities
8 July 2022 | Giuliana Miglierini

Domestic inspections represented in 2021 the majority of inspective activities, according to EFPIA’s Annual Regulatory GMP/GDP Inspection Survey. Mixed tools are playing an increasing role, even if the learning phase of implementation is still ongoing. Collaboration, reliance and delegation are among the suggestions to improve inspection practices in the future. In the UK, the MHRA launched a pilot programme focused on the new figure of Compliance Monitor consultants for the supervision of activities pharmaceutical companies have to implement on the basis of the Compliance Protocol agreed with the regulator following an inspection.
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EIC: challenges for the governance and opportunities for innovation
1 July 2022 | Giuliana Miglierini

While delays are still experienced with the signature of contracts and the availability of funding for companies entitled to access the EIC Accelerator programme, the EU Parliament launched an investigation on the current governance of the EIC. The EIC Pilot Expert Group has proposed to create two dedicated deep-training programmes to better support the development of entrepreneurial skills.
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Approval of the Data Governance Act, and EMA’s consultation on the protection of personal data in the CTIS
24 June 2022 | Giuliana Miglierini

The DGA will regulate the sharing and reuse of public-sector data. It describes the rules applying to data intermediation services, digital platforms for the sharing of data and data altruism. EMA has published a draft guideline on how to approach the protection of personal data within CTIS. A public consultation on the document is open.
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The transition towards EMA’s new Digital Application Dataset Integration (DADI) user interface
17 June 2022 | Giuliana Miglierini

EMA has published an updated timeline for the implementation of the new Digital Application Dataset Integration (DADI) user interface. The availability of the first web-form is expected in October 2022. The DADI project aims to improve interoperability of data and compliance to ISO IDMP standards for the identification of medicinal products, and to reduce the administrative burden for both the regulators and the industry
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IVD regulation in force: new MDCG guidelines and criticalities for innovation in diagnostics
10 June 2022 | Giuliana Miglierini

The IVD regulation (EU) 2017/746 entered into force on 26 May 2022. The Medical Devices Coordination Group issued some new guidelines to clarify its interface with the Clinical Trial regulation and the implementation of the Unique Device Identification system. The BioMed Alliance In Vitro Diagnostics Task Force published a paper to discuss the many still open challenges and issues, including the impact on in-house developed diagnostic tests and innovation.
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EMA’s consultation on draft Q&As on remote certification of batches by QP
3 June 2022 | Giuliana Miglierini

The public consultation of the Q&As’ draft guideline is open up to 13 June 2022. The document discusses how to address the routine remote certification and confirmation of batches, including requirements for the QPs and MIA holders
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Draft topics for the first IHI calls for proposals
27 May 2022 | Giuliana Miglierini

The IHI initiative published the draft text of the first two calls, expected to be launched in June. Innovative technologies are central to both, with a particular attention to digital health technologies and the possible contribution to prevention, diagnosis and treatment arising from artificial intelligence. Neurodegenerative diseases, cancer and cardiovascular diseases are the main therapeutic areas tackled by the announced topics, together with Early Feasibility Studies
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The PIC/S Annual Report 2021
20 May 2022 | Giuliana Miglierini

The Brasilian regulatory authority ANVISA is the 54th member of PIC/S. China’s FDA is among the regulatory authorities that filed a pre-accession procedure. In 2021 many new guidances were issued, and others are undergoing the process of revision
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Joint implementation plan for the IVDR regulation
13 May 2022 | Giuliana Miglierini

The Medical Devices Coordination Group updated the priorities of its Joint implementation and preparedness plan in view of the full entry into force of the IVDR regulation on 26 May 2022. Two distinct sets of actions are discussed in the document, those essential to ensure the presence of IVDs on the market and the high-priority ones to support the smoother transition to the new legislative framework governing in-vitro diagnostics
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Key issues in technical due diligences
6 May 2022 | Giuliana Miglierini

The acquisition of a pharmaceutical product requires the careful assessment of regulatory, quality and manufacturing elements and documentation as a part of the due diligence process. An exercise that may become highly complex in the case of an entire facility or a multi-site acquisition.
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A new joint work plan to 2023 for EMA and EUnetHTA 21
29 April 2022 | Giuliana Miglierini

The work plan defines the priorities of action to prepare for the entry into force of the new regulation (EU) 2021/228 on Heath Technology Assessment, including the setting up of the methodological and operative framework needed to support joint scientific consultations
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IPI, a new international procurement instrument at the EU level
22 April 2022 | Giuliana Miglierini

The European Council and Parliament reached on 14 March 2022 an agreement on the draft International Procurement Instrument (IPI). The entry into force of the new regulation will follow formal adoption by the two European Institutions. The new tool is expected to favour the expansion of European companies in third countries’ public procurement markets, on the basis of a reciprocity of access
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Trends in the development of new dosage forms
15 April 2022 | Giuliana Miglierini

New biotech medicines and advanced therapies often require the development of innovative formulations and dosage forms. Not only as injectables: oral solid dosage forms are more acceptable to patients, and may include smart elements to monitor compliance to treatment as well as physiological parameters. Patients’ preferences are also important to develop new formulations for the OTC market
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EDQM, the RTEMIS scheme for remote inspections and new application forms for CEPs
8 April 2022 | Giuliana Miglierini

After the closure of the pilot phase, in November 2021, the EDQM confirmed the Real-Time Remote Inspections (RTEMIS) programme as its third pillar to run inspective activities relative to GMP compliance and CEP certificates for API suppliers. The Directorate also released updated application forms for CEPs, and will soon launch its completely re-designed website
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Revision of the PIC/S GMP Guide: Annex 13 and Annex 16
1 April 2022 | Giuliana Miglierini

The Pharmaceutical Inspection Co-operation Scheme has updated its PIC/S GMP Guide. The revised Annex 13 reflects the new EU “Clinical Trials” regulation, while Annex 16 is completely new and addresses the certification and batch release processes which fall under the responsibility of the Authorised Persons
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Academic Research in industrial pharmacy field
29 March 2022 | Anni Svala

Industrial pharmacy specialization students from University of Helsinki, Terhi Liukko and Anni Svala, are conducting academic research of remote audits. To increase the knowledge of remote audits and sharing best practices, we kindly ask you to participate to the survey
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FAT and SAT, a critical step for the introduction of new equipment
25 March 2022 | Giuliana Miglierini

Factory acceptance testing and Site acceptance testing are key components of the commissioning process, as they support regulatory compliance to GMP and the overall quality and safety of pharmaceutical productions. A brief excerpt of the main features that should enter the planning of FAT and SAT testing
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The Made in Europe partnership for manufacturing
18 March 2022 | Giuliana Miglierini

The partnership includes all stakeholders interested in the development and sustainability of the European industrial sector. After a first set of actions launched in the contest of the Horizon Europe work programme 2021-2022, and aimed to support the green and digital transformation and circular economy, a preliminary consultation and discussions are ongoing to define the topics to be included in the new HE work programme 2023-2024
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The new Annex 21 to GMPs
11 March 2022 | Giuliana Miglierini

Provisions applying to the import in the EU/EEA of human and veterinary medicinal products and investigational medicinal products are specified in Annex 21, that will enter into force on 21 August 2022. The document details the responsibilities of the importation site responsible for QP certification/confirmation of imported batches, including those referred to the Pharmaceutical Quality System and available documentation
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The main contributions to the consultation on the revision of the pharmaceutical legislation
4 March 2022 | Giuliana Miglierini

The European Commission published the Summary Report and attached documentation received during the public consultation on the revision of the pharmaceutical legislation. We summarise the main contributions from pharmaceutical and allied associations
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Revision of the CDMh’s Q&As document on nitrosamine impurities
25 February 2022 | Giuliana Miglierini

Revision 5 of the CDMh document includes modification of terms for the lifting of Conditions B and D to the marketing authorisation. A Communication of the FDA specifies that formulation design strategies may represent a possible approach to limit the presence of nitrosamine impurities in the final medicinal product
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A record year for biotech investments in UK, a year after the Brexit’ factor
18 February 2022 | Giuliana Miglierini

A recent report published by the UK’s BioIndustry Association (BIA) and Clarivate illustrates the trends of investment in the biotech sector in 2021. The country confirmed its high attractiveness for investors, both with regard to venture capitals and IPOs
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Investing in formulation as success’ factor
11 February 2022 | Giuliana Miglierini

Early formulation studies pose many challenges, but represent a critical point to reduce the time-to-market needed to make available a new medicinal product to patients. Poor solubility of the active ingredient is often a main issue to be faced, together with the optimisation of its stability, bioavailability and manufacturability
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ACT EU: the EU’s vision for the future of clinical trials
4 February 2022 | Giuliana Miglierini

The strategic document “Accelerating Clinical Trials in the EU” released by the EU Commission, EMA and HMA indicates six objectives and ten specific actions for years 2022-2023 to improve the European framework for clinical trials and the attractiveness of Europe to host larger, multinational studies
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The European Medicines Regulatory Network Data Standardisation Strategy
28 January 2022 | Giuliana Miglierini

The document issued by EMA and the HMA discusses the principles and recommendations identified as requirements to achieve the harmonised adoption, adaptation and implementation, by regulatory authorities members of the EMRN, of common standards to manage data for regulatory purposes
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ICMRA published a Reflection paper on remote inspections
21 January 2022 | Giuliana Miglierini

The experience gathered by regulatory authorities at the international level during the pandemic was analysed by ICRMA’s working group to highlight critical issues and cases where this type of approach proved unfeasible. On-site inspections shall continue to be run also in future, suggests the regulators’ association. GMP and GCP inspections are discussed in detail in the document
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EMA’s Q&A on the integration of EudraGMDP and OMS
14 January 2022 | Giuliana Miglierini

The guideline resumes the questions posed in October 2021 during a live webinar organised by EMA to support interested parties with the transition to the new system, that will become fully operative since 28 January 2022, together with the new Veterinary Medicinal Products Regulation
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Draft Guideline on the acceptability of names for human medicinal products
7 January 2022 | EIPG

This update of the guideline further clarifies specific aspects of the criteria applied to address safety and public health concerns, international non-proprietary names issues and product-specific concerns in proposed (invented) names
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A study on medicines shortages from the European Commission
24 December 2021 | Giuliana Miglierini

The study was commissioned in March 2020; it suggests 16 possible policy measures that the Commission may consider while drafting a new legislative proposal, expected to be announced at the end of 2022
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EMA’s OMS has turned mandatory for centrally authorised products
17 December 2021 | Giuliana Miglierini

A new step in the compulsory use of Organisation Management Service (OMS) data has been implemented on November 1st, 2021. All organisations are required to verify and submit changes to their data, that will be validated by EMA before their use to submit applications for centrally authorised products. Further discussion is ongoing to extend the use of OMS data also to national procedures within the next couple of years
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Steps towards the final approval of the IP action plan
10 December 2021 | Giuliana Miglierini

The resolution approved by the European Parliament shall now be transmitted to the European Council. The document suggests how to improve the IP Action Plan presented in November 2020 by the Commission. Other suggestions came also from the industrial associations
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Greatest common divisor for product traceability and batch definition in continuous biomanufacturing
3 December 2021 | Giuliana Miglierini

An important challenge in continuous integrated biomanufacturing is represented by the method used to define production batches. An article published in the J. Chem. Technol. Biotechnol. discusses the possible use of the great common divisor to take into consideration the time-dependency and periodic behaviour of semi-continuous processes in order to achieve the optimal definition of the batch size
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Steps forward towards the new framework for HTA
26 November 2021 | Giuliana Miglierini

After the adoption by the Council of Europe, the HTA regulation should be also endorsed by the EU Parliament; it will come into force three years after publication in the EU Official Journal. To support the implementation phase, the new Heads of Agencies Group has been created; EUnetHTA 21 consortium has signed a Service Contract with HaDEA, and launched the first Open Call targeted to the pharmaceutical industry
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Commission establishes portfolio of 10 most promising treatments for Covid-19
19 November 2021 | Giuliana Miglierini

Antiviral monoclonal antibodies, oral antivirals and immunomodulators are the three categories of therapeutics the expert group identified as the most promising with respect to the rapid development and approval of new options for the treatment of the infection. The selected candidates may now access EMA’s scientific advice, regulatory flexibility pathways and HERA’s innovation support tools in order to undergo formal regulatory assessment and approval
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A new role for EMA and a pilot project for the repurposing of medicines
12 November 2021 | Giuliana Miglierini

The draft agreement reached by the Council of the EU and the European Parliament enlarges EMA’s action to the management of crisis preparedness, with a special focus on the availability of medicines and medical devices needed to face health emergencies. A pilot project was launched by the Agency to support the repurposing of off-patent medicines; research activities shall be run by not-for-profit organisations and the academia, while the pharmaceutical industry shall be responsible for the submission of requests of authorisation for the new indications
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A step forward towards the African Medicines Agency
5 November 2021 | Giuliana Miglierini

The formal ratification of the Treaty by Cameroon has started the count down towards the operative phase of implementation of AMA by the African Union. The newly born Agency will be responsible for the promotion and coordination of regulatory activities among the adhering countries, with the aim to reach a better harmonisation of the framework for medicines’ development, manufacturing and approval in Africa.
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Automation of aseptic manufacturing
29 October 2021 | Giuliana Miglierini

The presence of robots within closed isolators allows for the almost complete elimination of human operators from cleanrooms, thus reducing the risk of contamination. The available technologies are now highly standardised, and offer many opportunities for new designs of the manufacturing process, especially in the field of advanced therapies.
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First steps of the HERA Authority and comments from industrial and medical associations
22 October 2021 | Giuliana Miglierini

Three different calls for tender on antimicrobial resistance and strategic stockpiling of therapeutics to treat Covid-19 are the first activities launched by the EU Commission to provide the basis for the new European Health Emergency preparedness and Response Authority to become fully operative. Several stakeholders commented HERA’s objectives and possible approaches to the operative phase.
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Consultation on the reform of the European pharmaceutical legislation
15 October 2021 | Giuliana Miglierini

The initiative launched by the European Commission is open for comments until 21 December 2021. As established by the EU’s Pharmaceutical Strategy, it aims to collect opinions from all the different stakeholders as the first step towards the review of the current pharmaceutical legislation to better reflect the state-of-the-art in technology, innovation and regulatory sciences.
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Consultation open on the ICH Q13 guideline on continuous manufacturing
8 October 2021 | Giuliana Miglierini

The public consultation on the ICH Q13 guideline of continuous manufacturing of drug substances and drug products is open until 20 December 2021. The guideline provides the general framework for the development and operation of a CM system, both under the scientific and regulatory perspective. It also offers examples to illustrate the main features to be considered under the different domains of pharmaceutical manufacturing.
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The new guideline on combination products between medicines and medical devices
1 October 2021 | Giuliana Miglierini

The guideline published in July by EMA addresses integral, co-packaged and referenced medicinal products. It describes the quality information to be submitted to competent authorities as part of the authorisation dossier to prove compliance to requirements of the Medical Devices Regulation.
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Medical Cannabis in Europe
24 September 2021 | Giuliana Miglierini

The cultivation and manufacturing of cannabis-based medicinal products is rapidly expanding in many European countries. There is still lack of harmonised legislation governing the sector, many countries have developed internal laws to support investments in the field. In Germany the BfArM has started the state sell of domestic medical cannabis; Greece and Malta present favourable climatic locations for cultivation and have approved a specific regulatory framework.
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The Pact for Research and Innovation in Europe
17 September 2021 | Giuliana Miglierini

The proposal adopted by the EU Commission details the main features and approach to the realisation of the new European Research Area and calls member states to voluntary increase the level of R&I investments up to the 3% target planned for 2030.
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The opportunity for repurposing of oncology medicines
10 September 2021 | Giuliana Miglierini

Non-commercial repurposing of oncology medicines may offer interesting opportunities for treatment of rare cancers, but many issues still have to be solved. The topic has been debated during the last Joint meeting of EU Directors for Pharmaceutical Policy & Pharmaceutical Committee.
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A golden era for UK’s life sciences and a new Code of practice for its pharmaceutical industry
3 September 2021 | Giuliana Miglierini

The launch of the new Life Science Vision by the UK’s government has corresponded to a successful moment in the raising of investments in the biotech sector and to the publication of the new Code of Practice for the promotional activities of prescription medicines.
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Webinar: PBPK Modelling and Simulation
27 August 2021 | EIPG

Over the last 20 years Physiologically–Based Pharmacokinetic(PBPK) Modelling and Simulation has developed and is now used extensively within Discovery and Development in the Pharmaceutical Industry.EIPG’s and PIER’s next webinar,to be held on 21st October 2021.
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Artificial intelligence in medicine regulation
20 August 2021 | Giorgos Panoutsopoulos

The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published on 16 August 2021.
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Draft guidelines, open for consultation
13 August 2021 | EIPG

ICH guideline Q13 on continuous manufacturing of drug substances and drug products.
Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells.
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The Swiss interoperable national eHealth infrastructure
6 August 2021 | Giuliana Miglierini

The new strategy will be adopted by all Swiss university hospitals and academic institutions. It provides a common semantic framework to be used in synergy with the existing tools to meet the needs of both patients and the healthcare system.
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The new PIC/S guideline on data integrity
30 July 2021 | Giuliana Miglierini

The guideline is intended to support the work of inspectors for the verification of good data management practices and data integrity related to GMP/GDP activities in pharmaceutical manufacturing. Its adoption is not mandatory, and the principles described can apply to all elements of the Pharmaceutical Quality System.
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The new vision for the European research landscape
23 July 2021 | Giuliana Miglierini

Many activities are completely reshaping the European research landscape. The European Commission is negotiating with several third countries their participation to Horizon Europe’s projects. Many Science organisations have expressed their position about the current exclusion of Switzerland. Science Europe has published its new Strategy 2021-2026. Five industrial associations in the pharmaceutical and medtech sectors have published a Strategic Agenda for Research & Innovation in Healthcare to guide the new public-private partnerships planned under the proposed Innovative Health Initiative (IHI) framework.
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Small-scale models for process development
16 July 2021 | Giuliana Miglierini

SSMs are useful to simulate many different processes typical of biomanufacturing, both in early and late development. A series of articles on BioProcess Online discusses how to approach the implementation and qualification of small-scale models under an industrial perspective.
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EMA publishes Q&A document about Parallel Distribution
9 July 2021 | EIPG

The European Medicines Agency (EMA) has published a new document entitled “Frequently asked questions about parallel distribution” (EMA/297155/2021). The 30-page PDF file contains answers to the most common questions. .
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EIPG Virtual Symposium
The Post-COVID Era and Pharmacy
2 July 2021 | Jane Nicholson

Luigi Martini, Chief Scientist at the Royal Pharmaceutical Society chaired an EIPG Symposium on the lessons learned from the pandemic and how pharmacists can shape the future in a post-COVID era.
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