Optimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation

Transcription

1 TOPRA MODULE Optimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation Case study 2 - Management of Regulatory Affairs Department ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

2 Top level approach Top 3 areas of focus in general for this case study What processes need to be introduced? Ranking the issues in terms of order of priority what do they need to first? What should be tackled short/mid/longer term?

3 Question 1. What actions are you going to take in your first three months in the job with respect to this organisation? (1) Major MAA submissions Prioritising and reviewing projects Looking at current job descriptions roles and responsibilities with a view to move some tasks out Drawing up clear job descriptions Interviewing staff to gain feedback, e.g. ask what changes would make the biggest difference ask for ideas from all about how to achieve with limited resource ask about the quality/level of cooperation/common objectives with the other departments Present results back to the Department head. Talk at length about easy wins to improve morale Restructuring the department

4 Question 1. What actions are you going to take in your first three months in the job with respect to this organisation? (2) Establishing basic relations with other departments Meeting the head of PHV department to discuss needed actions to meet new requirements of PHV Regulations Staff incentives/starting a recruitment process Regular meetings with managers and department Global meetings & teleconferences Setting up a department meeting with the Global head. Make strong case for face-to-face event. Review 'how we do things' / share feedback, identify directions for change

5 Question 1. What actions are you going to take in your first three months in the job with respect to this organisation? (3) Reviewing the budget Audit of the department & Compliance Issues Reviewing available RA policies in the department (SOPs/WI etc.), preparing gap analysis and the list of RA policies needed for the work of the department Consider an external QA audit of the department Prepare short-medium-long-term Road-map SWOT analysis (An external consultant/facilitator may be needed for some of the things above)

6 Question 2. What changes, if any, would you make to the organisational structure? (1) Staff input needed to establish what works and what doesn t Set up teams with reporting lines to senior staff Start immediate recruitment for vacant positions As interim solution check availability of contractors Structure group by product then by phase (In case of same product in different phases, e.g. different indications, specific groups) Consider to set up a Maintenance Group Outsource publishing in the short term or put the responsibility to the US Outsource publishing in the short term or put the responsibility back to the US rather than hire a specialist. Set up reporting metrics to capture actual workload and planning/control You can align responsibilities by product groups and assign tasks that cover "routine" work (maintenance) and development projects as "highlights".

7 Question 2. What changes, if any, would you make to the organisational structure? (2) Promote staff with experience and who also perform well and have the most pro-active and business-focused attitude Buy Cortellis and introduce department meetings where knowledge is shared Consider for the future new position of Regulatory Intelligence Manager Set up labeling group (if RA department is responsible for labeling). Labeling is important, not necessarily covered by a scientist, but requires special attention (labeling mistakes are the most common cause for recalls, so any investment to avoid a recall will pay for itself) Mentoring schemes Longer term, bring Phase II and III applications back in-house (if it is not broke do not try and fix it). Get rid of the idea that you can get it right for everyone. (of course, try your best to make everybody feel happy to work in the department, but it is impossible to be everybody's darling.)

8 Question 4. How would you use the additional headcount and what are your recruitment tactics? Discuss with HR department and use their support Use external recruitment agency Use consultants in the interim Recruit internally Hire more junior staff Appoint an operations person Hire temporary admin staff Bring in a Publishing Expert Use existing staff to handle recruitment (delegate)

9 Question 5. How will you approach the resource assessment and justification of headcount? Assess long term plans Review standards of submissions Assess gap analysis FTE analysis Manual hours and financial review Examine similar sized companies Highlight existing manufacturing issues Use existing workload to justify the need for additional staff Determine how much work (time and cost) is currently outsourced Use Senior Managements complaints as support that staff workloads are currently too high. Raise the need for compliance work

10 Question 6. What technology and other support services would you consider introducing? Please give your reasons why you think they would be of benefit. Establish a regulatory database (summary of registration status of all products, renewals, variations, commitments, DL etc.) Departmental intranet Set up a collaboration area online. Put key documents on it, including meeting minutes and action lists. Make sure people use this instead on attachments Introduce systems and procedures to increase compliance and establish standards Establish Publishing Group Regulatory intelligence Cortellis (IDRAC) Website links to EMA, FDA etc Secondment from the US group Training and resource planning

11 Question 7. The company has in-licensed a new product that requires the co-development of an accompanying in vitro genetic test. Neither you nor anyone in your team has any experience in genetic testing. What actions will you take to provide regulatory support for this product? Secondment from the US group Hire consultant Out-sourcing to CRO Ask scientific advice from the agency as regards the range of testing Establish timelines and costs for testing

12 Question 8. Managing non-compliance (1) Meet key people from manufacture and QA compliance group to agree future collaboration and communication to avoid such situation in the future Discuss this issue with head of QA and agree the plan to ensure compliance of manufacturing and registration documentation Set up the plan for preparation of variation data package and timeline for submission With involvement of QA compliance get all variations that were not reviewed by RA Agree with QA future plan which should ensure compliance (prepare SOP, training of all relevant people) Agree with QA compliance plan for review of documentation of manufactured products Organize RA & QA & Manufacturing meeting to get all people involved and understand the problem

13 Question 8. Managing non-compliance (2) Set up liaison teams, or partnerships between the current product Regulatory reps and the responsible manufacturing managers. Get them to meet regularly and build/propose solutions together. Set up multi-departmental sign off for all changes Manufacturing, QA, RA and QP. This can be a simple 1 pager but it will make people realise that you need approval before making a change.

14 Question 9. What actions you will do address all PHV and safety issues? Prepare very short and clear summary of situation to your boss in the USA prepare crisis management plan Identify all the documents (PSMF, RMP) and deadline by when you need these documents Organise meeting with PHV department to find out what support they are providing, how communication works and what Sops are in place. Agree the next steps and find out what are their resources and capacity for the next period to cover your gaps. Review outcomes of 2 referrals and assess the impact on your products. Start immediate activities with submission of variations as per outcome of referrals. Communicate all planned actions to relevant functions (portfolio, product supply, local marketing, manufacturing sites, artwork etc.) in order to minimize impact on current stock of material and goods Prepare the safety-gap analysis plan together with PHV department Dedicate 1 contact person for collaboration and communication with PHV department